Pocket Drug Guide

Posts Tagged ‘HIV’

Daunorubicin 20mg Powder for I.V. Injection

(Daunorubicin Hydrochloride)

1. What Daunorubicin is and what it is used for

The name of your medicine is Daunorubicin 20mg Powder for I.V. Injection (called Daunorubicin in this post). It belongs to a group of medicines used to treat acute leukaemia,

Daunorubicin works by attacking and destroying the abnormal white blood cells which are present in a person with leukaemia.

Information about Leukaemia

Leukaemia is the name for a number of diseases of the white blood cells, which form part of your blood. These cells are produced in your bone marrow. In leukaemia, the white blood cells multiply in an uncontrolled and abnormal way.

The most common signs of leukaemia are:

•    Increased number of white cells in the blood. This causes easy bruising and nose bleeds

•    Feeling tired, faint, dizzy, having pale skin. These could be symptoms of anaemia

•    Extreme tiredness (exhaustion), and headaches

•    Bone and joint pain

•    Severe infection and fever

2. Before you are given Daunorubicin

Before treatment, you should discuss the risks and benefits of this medicine with your doctor.

Do not have Daunorubicin if:

•    You are sensitive to, or allergic to, Daunorubicin or other anthracyclines or any of the other ingredients of Daunorubicin

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

•    You have chicken pox or shingles, or you have been in recent contact with anyone who has chicken pox or shingles

•    You have an infection, fever or high temperature

•    You have any heart problems

•    You are pregnant or breast-feeding

•    You have a lot of mouth ulcers

Do not have Daunorubicin if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist.

Take special care with Daunorubicin

Check with your doctor, nurse or pharmacist before you are given Daunorubicin if:

•    You have had radiation treatment to the chest

•    You have had any other medicines to treat leukaemia (or cancer)

•    You have or have ever had gout

•    You have or have ever had kidney stones or any other kidney problems

•    You have any liver problems

•    You are sexually active, you are advised to use effective birth control to prevent pregnancy during treatment, whether you are male or female.

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before being given Daunorubicin.

• Using other medicines:

Special care will also be taken if you are taking any of the following medicines:

•    other medicines that may affect your heart for example, medicines to treat cancer such as 5-fluorouracil, cyclophosphamide, cisplatin, taxanes, calcium channel blockers used to control high blood pressure, chest pain, and irregular heartbeats and if you are receiving chest radiotherapy.

•    other medicines that may affect the bone marrow for example, other cancer treatments, sulphonamide, chloramphenicol (used to treat infection), diphenylhydantoin (used to treat epilepsy), amidopyrine-derivative (used to relieve pain), antiretroviral agents (used to treat HIV infection) may alter the formation of blood cells

•    other medicines that may affect your liver e.g barbiturates (drugs used in epilepsy or sleep disorders) and rifampicin (a drug used to treat TB – Tuberculosis)

•    live attenuated vaccines

Fertility, pregnancy and breast-feeding

Do not have Daunorubicin if you are pregnant, might become pregnant or think you might be pregnant as Daunorubicin can be very damaging to your unborn baby (embryo). If pregnancy occurs during treatment this should be discussed with your doctor.

Both female and male patients must take special precautions in their sexual activity if there is any possibility for pregnancy to occur:

•    For a Girl or woman of childbearing age:

You must have a negative pregnancy test before treatment and each month during treatment. This should be discussed with your doctor.

•    For Men:

Do not have sex with a pregnant woman unless you use a condom. This will lessen the possibility for Daunorubicin to be left in the woman’s body.

You and your female partner must each use an effective contraceptive during the time you are taking Daunorubicin and for 6 months after stopping treatment. This should be discussed with your doctor.

Men who wish to father children in the future should seek advice about freezing sperm before treatment with Daunorubicin is started.

If you are a woman who is breast-feeding, you must not take Daunorubicin. Discontinue breast-feeding before starting to take Daunorubicin.

• Driving and using machines

You may feel and/or be sick after being given this medicine, therefore special care should be taken when driving or using machines.

There is no information available about how Daunorubicin might affect your ability to drive or use machines.

3. How you will be given Daunorubicin

How Daunorubicin is given

•    Daunorubicin is a medicine used in hospitals

•    It will be given to you by a doctor or nurse as an injection into one of your veins

•    It will be given over about 20 minutes (this Is called an intravenous Infusion)

•    It should never be given as a single injection under the skin or into a muscle

•   The site of injection should not be covered or bandaged

Tell your doctor or nurse straight away if:

•   You have any pain, swelling or warmth around the vein where Daunorubicin is being injected

•   You notice that your face is red while the injection Is being given to you. This may be a sign that the injection is being given too quickly

How much Daunorubicin will be given

•   The exact dose will be determined by your doctor. It will depend on your age, height, weight and your general medical condition. The usual dose for a person weighing 70kg (12 stone) would be about 80mg

•   Your course of treatment may be altered, depending on how your body reacts to the medicine

•    Daunorubicin may be given alone or in combination with other medicines to treat or prevent side effects

Tests while having Daunorubicin

Your condition will be closely monitored during treatment. This may involve blood, urine tests or heart monitoring (called ECG).

If you have any questions about your course of treatment ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, Daunorubicin can cause side effects, although not everybody who is given this medicine will be affected in the same way. If you are worried about side effects you should discuss them with your doctor, who will explain the risks and benefits of your treatment. Some of the side effects can be lessened or treated by other medicines or therapy.

Tell your doctor, nurse or pharmacist straight away if:

•   You have pain, swelling or warmth in or around the vein where Daunorubicin is being injected

•   You have a red face while Daunorubicin is being injected. This may be a sign that the injection is being given too quickly

•   You get fevers, chills or other signs of infection

•   You have difficulty in breathing

•   You have swelling of the feet or legs

•   You have an uneven or fast heart beat

•   You have black or tarry bowel motions

•   You are being sick (vomiting) and bring up blood or dark brown coffee-coloured granules

•   You notice any unusual bleeding or bruising

Tell your doctor, nurse or pharmacist if you notice any of the following side effects:

•   You feel sick (nausea) or are sick (vomit)

•   You have diarrhoea

•   You have a skin rash

•   You have sores in the mouth or on the lips

Other side effects include:

•    decreased numbers of different types of blood cells (granulocytopenia, leukopenia and neutropenia, anaemia) which may cause tiredness, fever or increased risk of bleeding

•   feeling very dry and thirsty (dehydration)

•    inflammation of mucous membranes (mucositis), of the mouth with areas of painful erosions, ulceration and bleeding (stomatitis) and of the oesophagus (oesophagitis)

•    loss of appetite

•    increased pigmentation (hyperpigmentation) of skin and nails

•    Daunorubicin can make your urine turn red for a couple of days after each dose

•    Medicines like Daunorubicin often cause temporary loss of hair. After your treatment finishes your hair should grow back

Tell your doctor, nurse or pharmacist if any of the side effects gets serious, lasts longer than a few days, or if you notice any side effects not listed in the leaflet.

After stopping treatment

After you have finished your course of treatment, you may still get side effects. Tell your doctor, nurse or pharmacist straightaway if:

•   You have difficulty in breathing

•   You have swelling of the feet or legs

•   You get an uneven or fast heart beat

5. How to store Daunorubicin

•    Keep this medicine in a safe place out of the reach and sight of children.

•    Daunorubicin should not be used after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.

•   The vials of powder should be kept at room temperature and protected from light.

•   The Daunorubicin solutions made up from the powder should be stored at between 2 – 8°C, protected from light and used within 24 hours.

•    Following the injection, Daunorubicin will be disposed of carefully by the doctor or nurse.

•    Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Furher information

What Daunorubicin 20mg Powder for I.V. Injection contains

The active ingredient is Daunorubicin hydrochloride. Each vial contains 20mg of Daunorubicin. Each vial also contains mannitol.

What Daunorubicin 20mg Powder for I.V. Injection looks like and contents of the pack

Daunorubicin 20mg Powder for I.V. Injection comes as a vial containing a red powder. The solution prepared with this powder is also red. The vials are available in packs of 1 and 10 vials.

 

Cyprostat 100 mg tablet

(Cyproterone Acetate)

1. What Cyprostat 100 mg is and what it is used for

• What is Cyprostat 100 mg?

Cyprostat l00 mg is a medicine containing cyproterone acetate. It is an anti-androgen therapy. It blocks the actions of male sex hormones (androgens) and reduces the amount of male sex hormones produced by the body.

• What is Cyprostat 100 mg used for?

Cyprostat l00 mg is used in men to treat prostate cancer.

This medicine is used:

1.   to reduce the possible worsening of the disease which may occur when you start other treatments used for prostate cancer

2.  for long term treatment of prostate cancer when surgery or other medicines are not suitable

3.   to treat hot flushes which may occur during treatments with other medicines used for prostate cancer or following surgery.

2. Before you take Cyprostat

Do not take Cyprostat if you have:

• liver diseases (including previous or existing liver tumours (unless these are due to secondary cancers caused by prostate cancer), Dubin-Johnson Syndrome or Rotor Syndrome)

• any type of cancer (other than cancer of the prostate gland)

• ever been diagnosed with a meningioma (a generally benign tumour of the tissue layer between the brain and the skull). You should ask your doctor if you are in doubt

• wasting diseases (diseases involving an unintended loss of weight or muscle) except for prostate cancer that cannot be operated on

• blood clots (thrombosis or embolism)

Or  if:

• you are allergic (hypersensitive) to cyproterone acetate or any of the other ingredients of this medicine (see Section 6: Further information)

• you are under 18 years old if your testes or bones are not yet fully formed.

Take special care with Cyprostat:

Several blood tests or checks may be required while you are taking this medicine:

• liver problems, some of them severe or even fatal, have been reported with cyproterone acetate treatment. Your doctor may arrange for you to have regular liver tests before and during treatment to monitor this and may stop your treatment if necessary.

• using medicines such as Cyprostat has very rarely been linked to the development of benign (non-malignant) liver tumours and with some forms of liver cancer (malignant liver tumours). Liver tumours may lead to bleeding in the abdomen, which can be life-threatening. If you have any new stomach discomfort or pain that does not go away quickly, you must tell your doctor straightaway

• blood clots have been reported in patients taking this medicine which may also be linked to the reason you are taking Cyprostat. Tell your doctor if any of the following apply to you, as you may be at an increased risk of getting a blood clot. If you have:

a history of blood clots, strokes or heart attacks abnormal red blood cells (sickle -cell anaemia) severe diabetes that affects your blood circulation

• if you suffer from severe depression, this may get worse whilst you are taking Cyprostat. (See your doctor if you are affected by this)

• effects on the blood (anaemia) have been reported rarely during long term treatment with this medicine.

•  shortness of breath has been reported in patients taking this medicine at high doses (300mg daily)

•  Cyprostat can alter the sugar levels in your blood. If you are diabetic, check your blood sugar levels

regularly. Your doctor may alter the dose of medicine used to treat your diabetes

• Your doctor will check the function of your adrenal glands, as they may become suppressed during treatment with Cyprostat. Symptoms may include tiredness, fatigue, loss of appetite, weight loss, low blood sugar, low blood pressure, dehydration, headache, irritability and depression, aching muscles, abdominal pain, a craving for salty foods, feeling or being sick and diarrhoea.

Taking or using other medicines

Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

Some medicines may stop Cyprostat from working properly. Also, Cyprostat may change the way other medicines you are taking are broken down in your body.

Tell your doctor if you take any other medicines regularly, especially:

•      medicines such as rifampicin for the treatment of tuberculosis

•      medicines such as phenytoin used to treat epilepsy or other illnesses

•      products containing the herbal remedy commonly known as St John’s wort (Hypericum perforatum)

•      medicines such as ketoconazole, itraconazole, clotrimazole for the treatment of fungal conditions

•      medicines such as ritonavir used to treat HIV infections

•      cholesterol-lowering drugs such as statins. Cyprostat may make the side effects of statins worse, for example the breakdown of muscle

•      medicines such as glitazones used to treat diabetes.

If you are diabetic your doctor may need to alter the dose of medicine required to treat your diabetes. See also Section 2 ‘Take Special Care with Cyprostat l00 mg’.

Driving and using machines

You may feel tired and weak during treatment. If affected, do not drive, operate machinery or do anything where these symptoms may put either yourself or others at risk.

Important information about some of the ingredients in Cyprostat

If you have an intolerance to some sugars, check with your doctor before taking this medicine. This is because the tablets contain lactose (a type of sugar).

3. How to take Cyprostat

Your doctor will decide what dose you will take. Always take Cyprostat l00 mg exactly as your doctor has told you. You should check with your doctor if you are not sure.

Take the tablets after meals and swallow them whole with a drink of water.

The usual dose range is from 1 tablet once a day (l00 mg) up to 1 tablet three times a day (300mg).

• If you take more Cyprostat than you should

As soon as you can, talk to your doctor who will tell you what you need to do. There have been no reports of serious illness from taking too much Cyprostat in a single dose.

• If you forget to take Cyprostat

If you forget to take a dose, take it as soon as you remember and take the next dose when it is due. Do not take a double dose to make up for a forgotten dose.

• If you stop taking Cyprostat

Do not reduce the dose or stop taking your tablets unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cyprostat can cause side effects, although not everybody gets them.

If you have trouble breathing or swallowing, this may be a sign of a rare allergic reaction – contact your doctor or go to a hospital straight away.

These are the possible side effects of Cyprostat, starting with the more common ones:

Very common    more than 1 in 10 people may get these

• decreased sex drive impotence
• reduced sperm count reduced volume of ejaculate

Common       up to 1 in every 10 people may get these

• weight decrease or increase, which can be associated with fluid retention
• depressed mood
• restlessness
• breast swelling sometimes with tenderness
• hot flushes, sweating
• tiredness
• shortness of breath
• liver problems, some of them severe or even fatal, have been reported with dosages of 100 mg and above of cyproterone acetate. Your doctor may arrange for you to have regular liver tests during treatment to monitor this and may stop your treatment if necessary

Uncommon   up to 1 in every 100 people may get this

• rash

Rare    up to 1 in every 1000 people may get these

• allergic reaction (possibly causing a rash, itching or more rarely shortness of breath. If you have trouble breathing or swallowing, contact your doctor or go to a hospital straight away)
• tender lumps in the breasts and oozing of milky fluid from the nipples. These effects usually disappear if treatment is stopped or if the dose of Cyprostat is reduced

Very rare      less than 1 in every 10,000 people may get these

• benign (non-malignant) liver tumours,
• some forms of liver cancer (malignant liver tumours). Liver tumours may lead to bleeding in the abdomen, which can be life-threatening. If you have any new stomach discomfort or  pain that does not go away quickly, you must tell your doctor straightaway

Effects of Cyprostat on sperm

After you have been taking this medicine for some months, you may not have any sperm in your ejaculate. You will probably become unable to make anyone pregnant, but note that this does not happen at once. Do not rely on this medicine for contraception at any time. While the overall number of sperm that you produce will be reduced, more of your sperm than usual will be abnormal in shape. Some people think these abnormal sperm might possibly produce abnormal babies. Your doctor will be able to advise you further if you are thinking of having children.

Other changes that have been reported include:

•     blood clots have been reported in patients taking this medicine but they have     not definitely been linked to Cyprostat.

•      the occurrence of meningiomas (a generally benign tumour of the tissue layer between the brain and the skull) has been reported in association with longer term use (years) of Cyprostat at doses of 25 mg per day and above

•      dry skin and improvement in acne

•      temporary patchy loss of body hair, a reduction in hair growth on the body, an increased growth of hair on the head, lightening of hair colour, a female type of pubic hair growth

•      effects on the blood (anaemia) have been reported rarely during long term treatment with this medicine. Your doctor may arrange for you to have regular blood tests during treatment to monitor this

•      thinning of the bones (osteoporosis)

•     tiredness, fatigue, loss of appetite, weight loss, low blood sugar, low blood pressure, dehydration,

headache, irritability and depression, aching muscles (often muscle weakness), abdominal pain, a craving for salty foods, feeling or being sick and diarrhoea (suppressed adrenal glands).

After stopping treatment

After stopping treatment, the decrease in sex drive, reduction in sperm count and breast swelling will generally go back to normal.

If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor.

5. How to store Cyprostat

•    Keep out of the reach and sight of children.

•    Do not use Cyprostat after the expiry date which is stated on the box after the letters ‘EXP’. The expiry date refers to the last day of that month.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

What Cyprostat l00 mg contains

•    the active ingredient is cyproterone acetate. Each tablet contains l00 mg of cyproterone acetate.

•    the other ingredients are: maize starch, povidone 25000, magnesium stearate (E572), lactose.

What Cyprostat l00 mg looks like and contents of the pack

Each pack of Cyprostat l00 mg contains 84 tablets as 7 blister strips of 12 tablets.

 

Caelyx 2 mg/ml concentrate for solution for infusion

Pegylated liposomal doxorubicin hydrochloride

1.WHAT CAELYX IS AND WHAT IT IS USED FOR

Caelyx is an antitumour agent.

Caelyx is used to treat cancer of the breast in patients at risk for heart problems. Caelyx is also used to treat cancer of the ovary. It is used to kill cancer cells, shrink the size of the tumour, delay the growth of the tumour, and extend your survival.

Caelyx is also used in combination with another medicine, bortezomib, to treat multiple myeloma, a cancer of the blood in patients who have received at least 1 prior therapy.

Caelyx is also used to produce an improvement in your Kaposi’s sarcoma including flattening, lightening and even shrinkage of the cancer. Other symptoms of Kaposi’s sarcoma, such as swelling around the tumour, may also improve or disappear.

Caelyx contains a medicine which is able to interact with cells in such a way as to selectively kill cancer cells. The doxorubicin hydrochloride in Caelyx is enclosed in tiny spheres called pegylated liposomes which help to deliver the medicinal product from the blood stream to the cancerous tissue rather than healthy normal tissue.

2. BEFORE YOU USE CAELYX

• Do not use Caelyx

if you are allergic (hypersensitive) to doxorubicin hydrochloride or any of the other ingredients of Caelyx.

• Take special care with Caelyx

if you are receiving any treatment for heart disease or liver disease;

if you are diabetic, because Caelyx contains sugar which may require an adjustment to the treatment of your diabetes;

if you have Kaposi’s sarcoma and have had your spleen removed.

• Taking other medicines

Please tell your doctor or pharmacist

if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, about any other cancer treatments you are on or have been taking, as particular care needs to be taken with treatments which reduce the number of white blood cells, as this may cause further reduction in the number of white blood cells. If you are unsure about what treatments you have received or any illnesses you have had, discuss these with your doctor.

• Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Because the active ingredient doxorubicin hydrochloride in Caelyx may cause birth defects, it is important to tell your doctor if you think you are pregnant. Avoid becoming pregnant while you or your partner are taking Caelyx and in the six months following discontinuation of Caelyx treatment.

Because doxorubicin hydrochloride may be harmful to nursing infants, women must discontinue breast-feeding before starting treatment with Caelyx. Health experts recommend that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.

• Driving and using machines

Do not drive or use any tools or machines if you feel tired or sleepy from treatment with Caelyx.

3. HOW TO USE CAELYX

Caelyx is a unique formulation. It must not be used interchangeably with other formulations of doxorubicin hydrochloride.

Caelyx will be given to you by your doctor in a drip (infusion) into a vein. Depending on the dose and indication, this may take from 30 minutes to more than one hour (i.e., 90 minutes).

If you are being treated for breast cancer or ovarian cancer, Caelyx will be administered at a dose of 50 mg per square metre of your body surface area (based on your height and weight). The dose is repeated every 4 weeks for as long as the disease does not progress and you are able to tolerate the treatment.

If you are being treated for multiple myeloma, and have already received at least 1 prior therapy, Caelyx will be administered at a dose of 30 mg per square metre of your body surface area (based on your height and weight) as a 1 hour intravenous infusion on Day 4 of the bortezomib 3 week regimen immediately after the bortezomib infusion. The dose is repeated as long as you respond satisfactorily and tolerate treatment.

If you are being treated for Kaposi’sarcoma, Caelyx will be administered at a dose of 20 mg per square metre of your body surface area (based on your height and weight). The dose is repeated every 2 to 3 weeks for 2 – 3 months, then as often as necessary to maintain an improvement in your condition.

• If you use more Caelyx than you should

Acute overdosing worsens side effects like sores in the mouth or decreases the number of white blood cells and platelets in the blood. Treatment will include administration of antibiotics, platelet cell transfusions, use of factors which stimulate production of white blood cells and symptomatic treatment of mouth sores.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Caelyx can cause side effects, although not everybody gets them.

During the infusion of Caelyx, the following reactions may occur: flushing of the face, shortness of breath, headache, chills, back pain, tightness in the chest and/or throat, sore throat, low or increase in blood pressure, rapid heartbeat, puffing of the face, fever, dizziness, nausea, indigestion, itching, rash and sweating. In very rare cases, seizures (convulsions) have occurredStinging or swelling of the skin at the site of injection may also occur. If the drip stings or hurts while you are receiving a dose of Caelyx, tell your doctor immediately.

Contact your doctor immediately if:

• you get reddening painful skin on your hands and feet,
• you get painful reddening of the skin and/or blisters on the body or in the mouth,
• you get heart problems,
• you get mouth sores,
• you develop a fever or any other sign of an infection,
• you get sudden shortness of breath or sharp chest pain that may worsen with deep breathing or coughing,
• you get swelling, warmth, or tenderness in the soft tissues of your leg, sometimes with pain
• which gets worse when you stand or walk.

Between infusions, the following may occur:

• redness, swelling and sores on the palms of your hands and feet. These effects have been seen frequently, and are sometimes severe. In severe cases, these effects may interfere with certain daily activities, and may last for 4 weeks or longer before resolving completely. The doctor may wish to delay the start and/or reduce the dose of the next treatment (see Strategies to prevent and treat hand-foot syndrome, below);
• pain or sores in mouth or throat, nausea, vomiting, stomach pains, diarrhoea, constipation, oral thrush (a fungal infection in the mouth), sores in nose, bleeding from your nose, cold sores, loss of appetite, weight loss and tongue inflammation;
• decrease in the number of white blood cells, which can increase the chances of infections. Anaemia (reduction in red blood cells) may cause tiredness, and decreased platelets in the blood may increase the risk of bleeding. In rare cases, having low white blood cells may lead to severe infection. Laboratory values related to the function of the liver may either increase or decrease while on Caelyx. It is because of the potential changes in your blood cells that you will have regular blood tests. From a clinical study in patients with AIDS-KS comparing Caelyx against another treatment (bleomycin/vincristine), there may be a higher chance of some infections with Caelyx. However, in contrast to the experience with patients with AIDS-KS, when Caelyx was compared to a standard treatment for advanced ovarian cancer (topotecan), the risk of infections was substantially lower in the Caelyx-treated patients. The risk of low blood counts and infections was similarly low in breast cancer studies. Some of these effects may be related to your disease and not to Caelyx;
• general feeling of tiredness, sleepiness, confusion, dizziness, weakness, bone pain, breast pain, muscle pain, leg cramps or swelling, general swelling, inflammation of the retina (the light-detecting membrane of the eye), increased tear production, blurred vision, feeling of pins and needles or pain in hands and feet;
• hair loss, inflammation of hair follicles, scaly skin, inflammation or rash, abnormal skin pigmentation (colouring), and nail disorder ; heart problems, e.g., irregular heart beat, enlarged blood vessels;
• fever, increased temperature or any other sign of infection which may be related to your disease; respiratory problems, i.e., difficulty in breathing or coughing which may be linked to infections you have caught as a result of your disease; if you have previously had skin reactions, i.e., pain, redness and dryness of skin, during
• treatment with radiotherapy, this may also happen with Caelyx.

Other side effects that may occur with a combination of Caelyx and bortezomib include:

joint pain, decreased or abnormal sensation to stimulation, inflammation of the cornea, redness of the eye, redness of the scrotum.

When Caelyx is used alone, some of these effects are less likely to occur, and some have not occurred at all.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Strategies to prevent and treat hand-foot syndrome:

Every day for 4-7 days beginning immediately after you have received Caelyx:

soak hands and/or feet in basins of cold water when possible (e.g. while watching television, reading, or listening to the radio);

keep hands and feet uncovered (no gloves, socks, etc.);

stay in cool places;

take cool baths during hot weather;

avoid vigorous exercise that might cause trauma to the feet (e.g. jogging);

avoid exposure of skin to very hot water (e.g. Jacuzzis, saunas);

avoid tight fitting footwear or high-heeled shoes.

Pyridoxine (Vitamin B6):

Vitamin B6 is available without prescription.

Take 50-150 mg daily beginning at the first signs of redness or tingling.

5. HOW TO STORE CAELYX

Keep out of the reach and sight of children.

Store in a refrigerator (2°C – 8°C). Do not freeze.

After dilution:

Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C. Partially used vials must be discarded.

Do not use Caelyx after the expiry date which is stated on the label and carton.

Do not use Caelyx if you notice that it shows evidence of precipitation or any other particulate matter.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Caelyx contains

The active substance is doxorubicin hydrochloride. One ml of Caelyx contains 2 mg of doxorubicin hydrochloride in a pegylated liposomal formulation.

The other ingredients are a-(2-[l,2-distearoyl-s«-glycero(3)phosphooxy]ethylcarbamoyl)-e>-methoxypoly(oxyethylen)-40 sodium salt (MPEG-DSPE), fully hydrogenated soy phosphatidylcholine (HSPC), cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid and sodium hydroxide.

Caelyx concentrate for solution for infusion: vials which provide 10 ml (20 mg) or 25 ml (50 mg).

The following information is intended for medical or healthcare professionals only (see section 3):

Caution must be exercised in handling Caelyx solution. The use of gloves is required. If Caelyx comes into contact with skin or mucosa, wash immediately and thoroughly with soap and water. Caelyx must be handled and disposed of in a manner consistent with that of other anticancer medicinal products.

Determine the dose of Caelyx to be administered (based upon the recommended dose and the patient’s body surface area). Take the appropriate volume of Caelyx up into a sterile syringe. Aseptic technique must be strictly observed since no preservative or bacteriostatic agent is present in Caelyx. The appropriate dose of Caelyx must be diluted in 5 % (50 mg/ml) glucose solution for infusion prior to administration. For doses < 90 mg, dilute Caelyx in 250 ml, and for doses > 90 mg, dilute Caelyx in 500 ml.

To minimize the risk of infusion reactions, the initial dose is administered at a rate no greater than 1 mg/minute. If no infusion reaction is observed, subsequent Caelyx infusions may be administered over a 60-minute period.

In the breast cancer trial program, modification of the infusion was permitted for those patients experiencing an infusion reaction as follows: 5 % of the total dose was infused slowly over the first 15 minutes. If tolerated without reaction, the infusion rate was doubled for the next 15 minutes. If tolerated, the infusion was completed over the next hour for a total infusion time of 90 minutes.

If the patient experiences early symptoms or signs of infusion reaction, immediately discontinue the infusion, give appropriate premedications (antihistamine and/or short acting corticosteroid) and restart at a slower rate.

The use of any diluent other than 5 % (50 mg/ml) glucose solution for infusion, or the presence of any bacteriostatic agent such as benzyl alcohol may cause precipitation of Caelyx.

It is recommended that the Caelyx infusion line be connected through the side port of an intravenous infusion of 5 % (50 mg/ml) glucose. Infusion may be given through a peripheral vein. Do not use with in-line filters.

 

Androcur 50mg

Cyproterone Acetate

1. What is Androcur 50mg?

Androcur 50mg is a medicine containing cyproterone acetate. It is an anti-androgen therapy. It blocks the actions of male sex hormones (androgens) and reduces the amount of male sex hormones produced by the body.

What is Androcur 50mg used for?

Androcur 50mg is used to control sexual desire in men who have an increased sex drive (hypersexuality) and/or sexual deviation.

2. Before you take Androcur

•Your doctor may ask you to sign a witnessed agreement to treatment before prescribing Androcur 50mg. You may also have a test to check the number and function of your sperm before you start treatment as Androcur 50mg can affect this. The overall number of sperm you produce will be reduced and more sperm than usual will be abnormal in shape.

Do not take Androcur

If you have:

•      liver diseases (including previous or existing liver tumours, Dubin-Johnson Syndrome or Rotor syndrome)

•      any type of cancer (other than cancer of the prostate gland)

•      ever been diagnosed with a meningioma (a generally benign tumour of the tissue layer between the brain and the skull). You should ask your doctor if you are in doubt

•      wasting diseases (diseases involving an unintended loss of weight or muscle)

•     blood clots (thrombosis or embolism) or have ever had these

•      severe diabetes that affects your blood circulation

•      abnormal red blood cells (sickle-cell anaemia)

•      severe depression which you have had for many months or if:

•     you are allergic (hypersensitive) to cyproterone acetate or any of the other ingredients of Androcur 50mg

•     you are under 18 years old or if your testes or bones are not yet fully formed.

Take special care with Androcur:

Several blood tests or checks may be required while you are taking this medicine:

•liver problems, some of them severe or even fatal, have been reported with cyproterone acetate treatment. Your doctor may arrange for you to have regular liver tests before and during treatment to monitor this and may stop your treatment if necessary. See also section 4 ‘Possible side-effects’.

•using medicines such as Androcur has very rarely been linked to the development of benign (non-malignant) liver tumours and with some forms of liver cancer (malignant liver tumours). Liver tumours may lead to bleeding in the abdomen, which can be life-threatening. If you have any new stomach discomfort or pain that does not go away quickly, you must tell your doctor straightaway

•blood clots have been reported in patients taking this medicine which may also be linked to the reason you are receiving Androcur. Tell your doctor if any of the following apply to you, as you may be at an increased risk of getting a blood clot. If you have:

a history of blood clots, strokes or heart attacks

cancer

abnormal red blood cells (sickle-cell anaemia)

severe diabetes that affects your blood circulation

•effects on the blood (anaemia) have been reported rarely during long term treatment with this medicine. See also section 4 ‘Possible side effects’.

• shortness of breath has been reported in patients taking this medicine at high doses (300mg daily)

•Androcur can alter the sugar levels in your blood. If you are diabetic, check your blood sugar levels

regularly. Your doctor may alter the dose of medicine used to treat your diabetes

•Your doctor will check the function of your adrenal glands, as they may become suppressed during treatment with Androcur. Symptoms may include tiredness, fatigue, loss of appetite, weight loss, low blood sugar, low blood pressure, dehydration, headache, irritability and depression, aching muscles, abdominal pain, a craving for salty foods, feeling or being sick and diarrhoea.

Taking or using other medicines

Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

Some medicines may stop Androcur from working properly. Also Androcur may change the way other medicines you are taking are broken down in your body.

Tell your doctor if you take any other medicines regularly, especially:

• medicines such as rifampicin for the treatment of tuberculosis medicines such as phenytoin used to treat epilepsy or other illnesses
• products containing the herbal remedy commonly known as St John’s wort (Hypericum perforatum) medicines such as ketoconazole, itraconazole, clotrimazole for the treatment of fungal conditions medicines such as ritonavir used to treat HIV infections
• cholesterol-lowering drugs such as statins. Androcur may make the side effects of statins worse, for example the breakdown of muscle •     medicines such as glitazones used to treat diabetes.

If you are diabetic your doctor may need to alter the dose of medicine required to treat your diabetes. See Section 2 ‘Take Special care with Androcur’.

Taking with food and drink

Androcur 50mg does not work well in men who regularly drink a lot of alcohol.

Driving and using machines

You may feel tired and weak during treatment. If affected, do not drive, operate machinery or do anything where these symptoms may put either yourself or others at risk.

Important information about some of the ingredients in Androcur

If you have an intolerance to some sugars, check with your doctor before taking this medicine. This is because the tablets contain lactose (a type of sugar).

3. How to take Androcur

Your doctor will decide what dose you will take depending on your treatment. Always take Androcur exactly as your doctor has told you. You should check with your doctor if you are not sure.

•      The usual dose is 1 tablet twice a day. Once the desired effect is achieved, your dose may be gradually lowered.

•      Take the tablet after your morning and evening meals and swallow it whole with a drink of water.

Androcur 50mg is not for use in youths under 18 years old.

• If you take more Androcur than you should

As soon as you can, talk to your doctor who will tell you what you need to do. There have been no reports of serious illness from taking too much Androcur in a single dose.

• If you forget to take Androcur

If you forget to take a dose, take it as soon as you remember and take the next dose when it is due. Do not take a double dose to make up for a forgotten dose.

• If you stop taking Androcur

Do not reduce the dose or stop taking your tablets unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

• Possible side effects

Like all medicines, Androcur can cause side effects, although not everybody gets them.

If you have trouble breathing or swallowing, this may be a sign of a rare allergic reaction – contact your doctor or go to a hospital straight away.

For information on drinking alcohol while taking this medicine, see under Taking with food and drink in section 2 Before you take Androcur

These are the possible side effects of Androcur, starting with the more common ones:

Very common

Common

more than 1 in 10 people may get these

• reduced sperm count reduced volume of ejaculate
• up to 1 in every 10 people may get these
• weight decrease or increase, which can be associated with fluid retention
• depressed mood
• restlessness
• breast swelling sometimes with tenderness
• hot flushes, sweating
• tiredness
• shortness of breath
• liver problems, some of them severe or even fatal, have been reported with dosages of 100 mg and above of cyproterone acetate. Your doctor may arrange for you to have regular liver tests during treatment to monitor this and may stop your treatment if necessary

Uncommon

up to 1 in every 100 people may get this

rash

Rare

up to 1 in every 1000 people may get these

• allergic reaction (possibly causing a rash, itching or more
• rarely shortness of breath. If you have trouble breathing or swallowing, contact your
• doctor or go to a hospital straight away)
• tender lumps in the breasts and oozing of milky fluid from the nipples. These effects usually disappear if treatment is stopped or if the dose of Androcur is reduced

Very rare

• less than 1 in every 10,000 people may get these
• benign (non-malignant) liver tumours

Special

• some forms of liver cancer (malignant liver tumours). Liver tumours may lead to bleeding in the abdomen, which can be life-threatening. If you have any new stomach discomfort or pain that does not go away quickly, you must tell your doctor straightaway

Effects of Androcur on sperm

After you have been taking this medicine for some months, you may not have any sperm in your ejaculate. You will probably be unable to make anyone pregnant, but note that this does not happen at once. Do not rely on this medicine for contraception at any time. While the overall number of sperm that you produce will be reduced, more of your sperm than usual will be abnormal in shape. Some people think these abnormal sperm might possibly produce abnormal babies. Your doctor will be able to advise you further if you are thinking of having children.

Other changes that have been reported include:

•     blood clots have been reported in patients taking this medicine but they have not definitely been linked to Androcur. See also section 2 ‘Take Special Care with Androcur’

•      the occurrence of meningiomas (a generally benign tumour of the tissue layer between the brain and the skull) has been reported in association with longer term use (years) of Androcur at doses of 25 mg per day and above

•      dry skin and improvement in acne

•      temporary patchy loss of body hair, a reduction in hair growth on the body, an increased growth of hair on the head, lightening of hair colour, a female type of pubic hair growth

•      effects on the blood (anaemia) have been reported during long term treatment with this medicine. Your doctor may arrange for you to have regular blood tests during treatment to monitor this

•      thinning of the bones (osteoporosis)

•      tiredness, fatigue, loss of appetite, weight loss, low blood sugar, low blood pressure, dehydration, headache, irritability and depression, aching muscles (often muscle weakness), abdominal pain, a craving for salty foods, feeling or being sick and diarrhoea (suppressed adrenal glands).

After stopping treatment

After stopping treatment, the decrease in sex drive, reduction in sperm count and breast swelling will generally go back to normal.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5. How to store Androcur

•   Keep out of the reach and sight of children.

•   Do not use Androcur after the expiry date which is stated on the box after the letters ‘EXP’. The expiry date refers to the last day of that month.

•   Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

What Androcur 50mg contains:

•   the active ingredient is cyproterone acetate. Each tablet contains 50mg of cyproterone acetate

•   the other ingredients are: maize starch, povidone 25000, magnesium stearate (E572), lactose, silicon dioxide (aerosil) (E551).

What Androcur 50mg looks like and contents of the pack

Each pack of Androcur 50mg contains 56 round, white tablets.

 

Brand Name: Agenerase
Active Ingredient: amprenavir
Indication: For combination therapy with other antiretroviral agents for the treatment of HIV-1 infection
Company Name: Glaxo Wellcome
Availability: Prescription only

Introduction

Agenerase (amprenavir) – the first new protease inhibitor in two years – is the fifth protease inhibitor to reach the US market. Agenerase, developed by Vertex Pharmaceuticals, Inc. and licensed to Glaxo Wellcome, was approved by the FDA in April 1999.

Unlike most other protease inhibitors that have to be taken three times daily, Agenerase has a long half-life and can be given twice daily. Agenerase has been studied in treatment-naive HIV patients and those who had previously received reverse transcriptase inhibitors and protease inhibitors.

How It Works

Agenerase (amprenavir) is an inhibitor of HIV-1 protease. It binds to the active site of HIV-1 protease and thereby prevents the processing of viral gag and gag-pol polyprotein precursors, resulting in the formation of immature non-infectious viral particles.

Agenerase (amprenavir): Clinical Study Results
A randomized, double-blind, placebo-controlled, multicenter study in therapy-naive adults is ongoing. Treatment with Agenerase (1200 mg twice daily) plus lamivudine (150 mg twice daily) plus zidovudine (300 mg twice daily) was compared with lamivudine (150 mg twice daily) plus zidovudine (300 mg twice daily) in 232 patients. Throughout the 24 weeks of therapy, there were no significant differences in median CD4 cell count between the treatment arms. At week 24, 53% of the Agenerase group had achieved a viral load of less than 400 copies/ml.

The efficacy of Agenerase was also examined in a randomized, open-label study in previously treated adults. Agenerase (1200 mg twice daily) plus nucleoside reverse transcriptase inhibitors (NRTIs) was compared with indinavir (800 mg every 8 hours) plus NRTIs in 504 patients. These patients were NRTI and non-nucleoside reverse transcriptase inhibitor (NNRI) experienced, and protease inhibitor naive. Through 24 weeks of therapy, there was a smaller increase in median CD4 cell count from baseline in the Agenerase group than in the indinavir group. At week 24, 43% of patients in the Agenerase group had achieved a viral load of less than 400 copies/ml.

The most commonly reported adverse effects in the trials included nausea, diarrhea, vomiting, rash, and perioral paresthesia. Severe and life-threatening skin reactions, including Stevens-Johnson syndrome, have occurred in 1% of patients treated with Agenerase. As with other protease inhibitors, Agenerase may be associated with acute hemolytic anemia, diabetes mellitus, and hyperglycemia. Agenerase does not seem to have a significant effect on the lipid profile.

Agenerase (amprenavir) may be taken with or without food, but should not be taken with a high fat meal. Agenerase is metabolized in the liver by ctyochrome P450 CYP3A4 and also inhibits this enzyme. Therefore, patients with hepatic dysfunction require dose adjustment. Caution should be used when coadministering medications that are substrates, inhibitors, or inducers of CYP3A4 or potentially toxic medications that are metabolized by CYP3A4.

An oral solution of Agenerase is available for pediatric patients. The bioavailability of this formulation is 14% lower than that of the capsules; therefore, the oral solution is not interchangeable with the capsules on a milligram per milligram basis.

What The Patient Should Know

Agenerase does not cure HIV infection and it is not known if Agenerase will help the patient live longer or have fewer medical problems, such as opportunistic infections. There are no data suggesting that Agenerase, or any other anti-HIV medications reduce the risk of viral transmission via sexual contact or blood contamination.

Agenerase (amprenavir) should always be used in combination with other antiretroviral drugs to limit development of resistance. Patients should not alter the dose or discontinue therapy without consulting their doctor.

Common side effects of Agenerase include nausea, vomiting, diarrhea, rash, and a tingling sensation around the mouth. Severe or life-threatening rash has been reported.

Agenerase (amprenavir), as with other protease inhibitors, may interact with many drugs. The patient, therefore, should inform the physician about any other medications that are being used, including non-prescription drugs.

The following medications should not be taken with Agenerase : Halcion ® (triazolam), Hismanal ® (astemizole), Ergot medications (Cafergot ® and others), Propulsid ® (cisapride), Versed ® (midazolam), and Vascor ® (bepridil). There are many other medications that have to be used with caution or not used at all while taking Agenerase.

Since Agenerase capsules and solution both contain large amounts of vitamin E, patients should not to take additional vitamin E while taking Agenerase.

Agenerase may be taken with or without food, but should not be taken with a high fat meal.

Agenerase (amprenavir) is a sulfonamide. Although the potential for cross-sensitivity between Agenerase and other sulfonamides is unknown, patients with a known sulfonamide allergy should be treated with caution.

Brand Name: Sustiva
Active Ingredient: efavirenz
Indication: For use in combination treatment of HIV infection (AIDS)
Company Name: DuPont Pharmaceuticals
Availability: FDA granted accelerated approval in September 1998; FDA granted traditional (full) approval based on long-term efficacy in February 2000

Introduction

Although several different types of drugs are used by patients with AIDS to treat their human immunodeficiency virus (HIV) infection (usually in combination), until recently no drug has received full approval from the FDA based on long-term results. In February 2000, Sustiva (efavirenz), manufactured by DuPont Pharmaceuticals, became the first anti-HIV drug to receive full FDA approval based on long-term data supporting its effectiveness in fighting HIV infection.

Sustiva had originally received accelerated approval from the FDA in September 1998 to make it available to patients with AIDS. The drug is used to treat AIDS only when taken with other anti-HIV medications that the patient has not received before. Taking Sustiva alone could make the AIDS virus become resistant to the drug. Sustiva is taken as three capsules once a day, and can be used by both adults and children over age 3 who have HIV infection.

Sustiva: Clinical Study Results

When taken with other anti-HIV drugs, Sustiva has been shown to reduce the amount of HIV in the blood (so-called viral load) and increase the number of a type of immune system cell called CD4. Two clinical studies have shown that patients who take Sustiva in combination with two other “antiretroviral” drugs (such as zidovudine, lamivudine, or nelfinavir) experienced a greater reduction in their viral load and that the treatment lasted longer than drug combinations that did not include Sustiva. One study demonstrated this response to treatment for up to 110 weeks so far, and the study is continuing.

“It is not only important for HIV medications to bring the level of virus in the blood down to below detectable levels, but maintain it this way for as long as possible,” said Dr. Cal Cohen, Director, Community Research Initiative of New England. “The long-term data on Sustiva used by the FDA clearly show that this drug, in combination with others, can be successful in achieving this goal.”

What You Should Know

The most common side effects reported by patients taking Sustiva are dizziness, insomnia, impaired concentration, drowsiness, abnormal dreaming, and mild to moderate rash. These symptoms occur early in treatment and generally resolve in two to four weeks. The incidence and frequency of severe rash are higher in children than adults. Patients experiencing drowsiness or similar nervous-system symptoms are advised to avoid driving or operating heavy machinery. Because Sustiva has been associated with birth defects in animal studies, it should not be taken by pregnant women.