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NIPENT 10MG POWDER FOR SOLUTION FOR INJECTION POWDER FOR SOLUTION FOR INFUSION

Active substance(s): PENTOSTATIN

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
NIPENT® 10 mg
Powder for solution for injection, powder for solution for infusion
(Pentostatin)
Read all of this leaflet carefully before you start using this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask 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.
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 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.
Please discuss with your doctor if after you have received Nipent you
suffer from for example: confusion, dizziness, sleep disturbance, pins
and needles, forgetfulness, staggering walk, twitching, shaking, fainting,
headache, fits or other conditions of the nervous system.

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 is not recommended if you are pregnant. Please tell your doctor if
you are 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 may feel unwell or suffer from dizziness or sight problems after being
given this medicine. You should not drive or operate machinery if you suffer
from these side effects.

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, severe chest pain which
may also affect your arm and neck (heart attack).

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)
• stomach pain or feeling or being sick

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.











loss of appetite
diarrhoea or blood in the stools
headache
cough, runny nose, cold, sore throat or breathing problems
rash, itchy skin or skin problems
muscle pain, joint or bone problems
tiredness, weakness or pain
fever, sweating or chills
jaundice

Common (occurs in fewer than 1 in 10 people)
• abdominal pain, indigestion, bloating or gas, constipation, weight change
• inflammation of the gums (gingivitis), mouth or lips or swelling of the
throat
• teeth problems, taste changes, dry mouth
• dehydration
• mood swings, aggression, anxiety, nervousness, depression, strange
dreams or thoughts, hallucinations, neurosis
• confusion, memory loss
• dizziness, shaking of the body or limbs, twitching, fits, fainting
• trouble sleeping or feeling sleepy
• staggering walk, speech disorder, paralysis, inflammation of the
coverings of the brain, nerve damage
• rash, flaking, swelling, redness, infection or itching of the skin
• dry skin, acne, oily skin, discolouration of the skin, skin sensitivity to light
• hair loss
• dry eyes or altered tear production, eye pain, eye infections, eye
sensitivity to light, changes in vision and damage to the back of the eye
(retina)
• ringing in the ears, pain in the ears, deafness, balance problems, vertigo
• shortness of breath, asthma, blood clot or fluid in the lungs, nose bleeds
• irregular, slow or fast heart beat, changes to the ECG, high or low blood
pressure, shock
• chest pain, angina, fluid around the heart, heart failure, heart arrest
• blood clots in or inflammation of the veins, bleeding
• infections such as sinusitis, pneumonia or bronchitis, abscesses, bone,
skin, kidney or urinary tract infections, fungal infections (eg mouth
thrush), shingles
• skin cancer or other cancers, leukaemia
• problems following a transplant
• enlarged spleen, bruising, enlarged lymph nodes
• gout, changes in the electrolytes in your blood (eg sodium, potassium
and calcium)
• arthritis, joint problems
• kidney disorders, difficulty or pain when passing urine, kidney failure,
stones in the kidney, inability to empty the bladder
• lack of periods, lumps in breasts, impotence
Uncommon (occurs in fewer than 1 in 100 people)
• gastroenteritis, Clostridium Difficile bowel infection
• infections such as bladder (cystitis), CMV (Cytomegalovirus), fungal lung
infection
• tumour lysis syndrome (involves breakdown products of dying cancer
cells)
• specific problems with red blood cells (Pure Red Cell Aplasia and certain
types of anaemia), red or purple skin marks due to low platelet count
• graft failure
• heart attack, heart muscle problems, low oxygen levels in the blood
• organ failure
• severe breathing problems
Rare (occurs in fewer than 1 in 1000 people)
• Alzheimer’s disease (memory loss, problems thinking and speaking)
• epileptic fits
• migraine
• Parkinson’s disease (loss of co-ordination, shaking of body and limbs)
• swelling of eyelids
• inflammation of the covering of the heart, reduction in heart function
• fungal infection of the food pipe (oesophagus)
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)
• changed blood results for liver or kidney function
Common (occurs in fewer than 1 in 10 people)
• 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
What Nipent contains:
The active substance is pentostatin. Each glass vial contains 10 mg of the
active ingredient.
The other ingredients are mannitol, sodium hydroxide or hydrochloric acid.

What Nipent looks like and contents of the pack:
Nipent is a white powder which is made into a solution by adding sterile
water before it is given as an injection or infusion.
Nipent is supplied in single-dose, 10 mg vials packaged in individual cartons
(packs of 1 vial).

The Marketing Authorisation Holder and Manufacturer is:
Hospira UK Limited,
Queensway,
Royal Leamington Spa,
Warwickshire,
CV31 3RW,
UK.
This leaflet was last approved in: 08/2012

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.
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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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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