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Hospira

PACKAGE LEAFLET: INFORMATION FOR THE USER

NIPENT® 10 mg

Powder for solution for injection, powder for solution for infusion

(Pentostatin)

In this leaflet:

1.    What Nipent is and what it is used for

2.    Before you use Nipent

3.    How to use Nipent

4.    Possible side effects

5.    How to store Nipent

6.    Further Information

1. WHAT NIPENT IS AND WHAT IT IS USED FOR

Nipent is an anti-cancer medicine used to treat adults with hairy cell leukaemia, a form of cancer affecting lymphocytes (white blood cells important for fighting invading viruses and bacteria).

2. BEFORE YOU USE NIPENT

Do not use Nipent:

•    if you have ever had an allergic reaction to Nipent (pentostatin) or mannitol

•    if you have impaired kidney function (creatinine clearance < 60 ml/min)

•    if you have an infection (raised temperature or fever, chills or feeling of achiness)

Tell your doctor if any of the above applies to you before this medicine is used.

Nipent is not recommended for use in children.

Take special care with Nipent:

•    if you have liver problems

Tell your doctor if either of the above applies to you before this medicine is used.

Tests

Before receiving Nipent for the first time, your kidneys will be checked to make sure that they are working normally. A blood test will also be done and repeated regularly during your treatment with Nipent.

Taking other medicines

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

Nipent should not be used with:

•    fludarabine (other anti-cancer medicine)

Tell your doctor if you are taking the following:

•    vidarabine (anti-viral drug)

•    cyclophosphamide, etoposide, carmustine (other anti-cancer medicines)

•    allopurinol (medicine used to treat gout, high levels of uric acid in the body caused by certain cancer medications, and kidney stones)

Pregnancy and breast-feeding

Nipent must not be used if you are pregnant. Please tell your doctor if you are you pregnant, trying to become pregnant or breast-feeding.

If you are of child bearing age you

must use appropriate contraceptive methods. Should you become pregnant, consult your doctor.

Men should not attempt to father any children during treatment or for 6 months after stopping Nipent therapy.

Driving and operating machinery

You should not drive or operate machinery until you know how Nipent affects you and it is safe to do so.

3. HOW TO USE NIPENT

Your medicine will always be given to you under the supervision of a doctor.

Dosage

Your doctor will work out exactly how much you need according to your height, weight and state of health.

The normal dose for adults including the elderly is 4 mg/m² given every other week. This medicine is given as a single short injection or a longer 20-30 minute infusion (drip) into your vein.

Before and after being given Nipent you will also receive an infusion into your vein of a solution (dextrose or dextrose saline) to ensure there is plenty of fluid in your body. This will help get the medicine to where it is needed and reduce any side effects.

Treatment Duration

You will be treated with Nipent until the cancer cells have been destroyed. Your doctor will check 6 and 12 months after you started receiving Nipent that you are responding to treatment.

4. POSSIBLE SIDE EFFECTS

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

Nipent works by killing cancer cells, but sometimes it also kills some of your normal blood cells, which can increase the chance of you getting an infection. It can also lower the number of platelets (which are necessary for proper blood clotting). Your doctor will be checking your condition, and will tell you if this occurs. There are certain precautions you can take, to reduce the risk of infection or bleeding. If possible, avoid people with infections.

•    Check with your doctor immediately if you think you are getting an infection or if you get a fever, sweating or chills, cough or hoarseness, difficulty swallowing, sores in the mouth or on lips, swollen runny nose, painful sinuses, lower back or side pain, pain, inability or difficulty when urinating (passing water), severe headache with confusion (encephalitis).

•    Check with your doctor immediately if you notice any unusual bleeding, nosebleeds or bruising, black tarry stools, blood in urine or stools, pinpoint red spots on your skin, sore throat, jaundice (yellowing of whites of the eyes and skin, pale stools or dark urine), allergic reactions (e.g. severe rash, difficulty in breathing, runny nose, swelling of the face, painful sores in the mouth), tremor, twitching.

Consult with your doctor or nurse as soon as possible if any of the following side effects occur:

Very common (occurs in more than 1 in 10 people)

•    headache

•    feeling or being sick

•    cough or hoarseness

•    diarrhoea

•    stomach pain

•    loss of appetite

•    rash

•    problems with or itchy skin

•    muscle pain

•    joint or bone problems

•    sweating

•    fever

•    tiredness

•    chills

•    weakness or pain

•    blood test results for liver or kidney function may change

Common (occurs in fewer than 1 in 10 people)

•    dizziness

•    sudden skin rash

NIPENT^® 10 mg

Powder for solution for injection, powder for solution for infusion

The following information is intended for medical or healthcare professionals only:

To be administered by bolus intravenous injection or intravenous infusion. Do not administer by any other route.

Instructions on preparation and dilution:

Any unused product or waste material should be disposed of in accordance with local requirements.

Prescribers should refer to national or recognised guidelines on handling cytotoxic agents.

Procedures for proper handling and disposal of anticancer drugs should be followed.

1.    Reconstitution of Nipent should only be carried out by trained personnel in a cytotoxic-designated area.

2.    Adequate protective gloves should be worn.

3.    The cytotoxic preparation should not be handled by pregnant staff.

4.    Adequate care and precautions should be taken in the disposal of items syringes, needles etc. used to reconstitute cytotoxic drugs.

5.    Contaminated surfaces should be washed with copious amounts of water.

6.    Any remaining solution should be discarded.

Transfer 5 ml of Sterile Water for Injection to the vial containing Nipent and mix thoroughly to obtain complete dissolution. The solution should be colourless to pale yellow and yield 2 mg/ml pentostatin. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

swelling, redness or infection of skin/ abscess

sore or red eyes flaking or itching of the skin weight change

problems when going to the toilet

swelling of face, feet or lower legs

anxiety

depression

nervousness

strange dreams

mood swings

hallucinations

decrease in sex drive

aggression

strange thoughts

confusion

trouble in sleeping

loss of water from body (dehydration)

hangover taste changes dry mouth memory loss loss of co-ordination fits

shaking of the body or limbs

hyperactivity

dry eyes

eye pain

speech problems nerve pain

loss of ability to move a body part

fainting

twitching

eye and skin sensitivity to light

changes in vision

balance problems

increase in tear production

pain in the ears

shock

deafness

ringing in the ears

chest pain

irregular, slow or fast heartbeat redness of the face bleeding or bruising high or low blood pressure pneumonia or bronchitis shortness of breath breathing problems abdominal pain indigestion teeth problems

swollen gums, tongue, mouth or back of throat

cold sores shingles constipation bloating or gas dry skin acne

skin eruptions or growths hair loss discoloured skin oily skin back pain

aching bones or joints bone infection

numbness or tingling of hands or feet

gout

cramps in lower legs stiff neck lack of periods lumps in breast impotence

fungal infection of the skin, mouth or throat (thrush)

swelling of the lymph nodes blood clot or fluid in lungs problems following transplant

inflammation of a vein which may be caused by a blood clot

changes in blood test results for electrolytes (sodium, potassium and calcium)

high blood sugar levels

Uncommon (occurs in fewer than 1 in 100 people)

•    Collapsed lung, lung problems, organ failure, pain in hands or feet

Rare (occurs in fewer than 1 in 1000 people)

•    Alzheimer's disease (memory loss, problems thinking and speaking)

•    epileptic fits    ₌

•    severe headache

•    Parkinson's disease (loss of co-ordination, shaking of body and limbs)

•    swelling of eyelids

Very rare (occurs in fewer than 1 in 10,000 people)

•    Severe eye pain with vision loss

This medicine may also cause the following side effects that your doctor will watch for:

Very common (occurs in more than 1 in 10 people)

•    Blood disorders affecting red blood cells, white blood cells and platelets (clotting factors)

Common (occurs in fewer than 1 in 10 people)

•    Liver or kidney problems including kidney stones

•    swollen glands

•    heart and circulation problems

•    an enlarged spleen

Sometimes the effects of Nipent may not occur until months or years after the medicine is used and, in some cases, severe side effects have caused fatalities. These delayed effects may commonly include the development of certain types of cancer (e.g. skin and acute leukaemia). Discuss these possible effects with your doctor.

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 NIPENT

Keep out of the reach and sight of children.

Do not use Nipent after the expiry date printed on the vial label and carton (after “EXP”). Where only a month and year is stated, the expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C).

Prepared injections or infusions should be used immediately, however, if this is not possible they may be stored for up to 8 hours below 25°C.

6. FURTHER INFORMATION

Nipent may be given intravenously by bolus injection or diluted in a larger volume (25 to 50 ml) with 5% Dextrose Injection (5% glucose solution) or 0.9% Sodium Chloride Injection (0.9% saline solution). Dilution of the entire contents of a reconstituted vial with 25 ml or 50 ml provides a pentostatin concentration of 0.33 mg/ml or 0.18 mg/ml, respectively, for the diluted solutions.

Nipent solution when diluted for infusion with 5% Dextrose Injection (5% glucose solution) or 0.9% Sodium Chloride Injection (0.9% saline solution) does not interact with PVC infusion containers or administration sets at concentrations of 0.18 mg/ml to 0.33 mg/ml.

Acidic solutions should be avoided (the pH of the reconstituted powder is 7.0 to 8.2).

Storage and shelf life:

The reconstituted solution for injection or reconstituted and further diluted solution for infusion should be used within 8 hours and should not be stored above 25°C. Immediate administration after reconstitution is recommended.

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