Pentostatin parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusions of pentostatin
Drugs List
Therapeutic Indications
Uses
Leukaemia - hairy cell
Single agent treatment for hairy cell leukaemia.
Dosage
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
Adults
A dose of 4mg/metre squared should be given every other week either as an intravenous bolus injection or an intravenous infusion (see Administration section).
It is recommended that patients receive hydration before and after pentostatin administration (see Dosage - Additional Dosage Information section).
Elderly
A dose of 4mg/metre squared should be given every other week either as an intravenous bolus injection or an intravenous infusion (see Administration section).
It is recommended that patients receive hydration before and after pentostatin administration (see Dosage - Additional Dosage Information section).
Patients with Renal Impairment
The manufacturer states that pentostatin use is contraindicated in patients with creatinine clearance of less than 60ml/min.
The Renal Drug Handbook suggests 50% of the usual dose in patient with a glomerular filtration rate (GFR) of 50 - 60ml/min.
Additional Dosage Information
Hydration
It is recommended that patients receive hydration before pentostatin administration with either 500 ml or 1000 ml of:
1.) 5% glucose only OR
2.) 5% glucose in 0.18% saline (sodium chloride) OR
3.) 5% glucose in 0.9% saline OR
4.) 3.3% glucose in 0.3% saline OR
5.) 2.5% glucose in 0.45% saline
An additional 500 ml of:
1.) 5% glucose only OR
2.) 5% glucose in 0.18% saline OR
3.) 5% glucose in 0.9% saline OR
4.) 2.5% glucose in 0.45% saline
should be given after pentostatin administration.
Administration
To be given as an intravenous bolus injection or as an intravenous infusion over 20-30 minutes.
Contraindications
Acute infection
Children under 18 years
Breastfeeding
Pregnancy
Renal impairment - creatinine clearance below 60ml/minute
Precautions and Warnings
Performance status of ECOG greater than 2
Hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Maintain adequate hydration of patient prior / during treatment
Treat and control infections prior to commencing therapy
Treatment to be initiated and supervised by a specialist
Consult local policy on the safe use of anti-cancer drugs
Staff: Not to be handled by pregnant staff
Monitor and discontinue if appropriate if psychiatric or CNS problems occur
Monitor blood counts regularly
Monitor blood urea nitrogen (BUN)
Monitor for signs of bone marrow depression
Monitor patients for signs of tumour lysis syndrome
Monitor serum creatinine before each dose
Suspend treatment if neutrophil count <200 cells per cubic mm
Withdraw drug in the case of worsening rash or severe skin reactions
Consider interrupting treatment if infection occurs
Female: Ensure adequate contraception during treatment
Male: Contraception required during and for 6 months after treatment
Myelosuppression, especially during the first few courses of treatment, may occur. Patients who develop infections prior to treatment with pentostatin have, in some cases, experienced a deterioration in their condition leading to death. Therefore, efforts should be made to control infections prior to treatment with pentostatin.
Frequent whole blood counts should be performed, especially during the initial cycles of pentostatin treatment when neutropenia is expected to be exacerbated. If the absolute neutrophil count (ANC) falls below 200 cells/cubic millimetre in a patient with an initial ANC of greater than 500 cells/ cubic millimetre, pentostatin should be withheld. Treatment may resume once counts return to pre-dose levels.
Response to treatment should be determined by periodic monitoring of peripheral blood for hairy cells and possibly bone marrow aspirates and biopsies at 2-3 month intervals.
Pregnancy and Lactation
Pregnancy
Pentostatin is contraindicated during pregnancy.
In mice and rats, pentostatin is teratogenic. It is also potentially genotoxic.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
It is unknown if pentostatin is excreted in human milk but given the potential for serious adverse events, breastfeeding is contraindicated during treatment.
Hale (2014) recommends withholding breastfeeding for at least 2 days after the last dose or if there is renal impairment, at least 5 days afterwards.
Briggs and Freeman (10th Edition) recommends pumping and discarding milk for 30 hours after treatment to limit the infant's exposure to pentostatin in the mother's milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Abnormal liver function tests
Abscess
Acute leukaemia
Adult respiratory distress syndrome
Agranulocytosis
Allergic reaction
Amenorrhoea
Anaemia
Anorexia
Arthralgia
Asthenia
Asthma
Atrial fibrillation
Autoimmune disorders
Bilirubinuria
Bleeding gums
Blood pressure changes
Cardiovascular disturbances
Chills
Confusion
Congestive cardiac failure
Cough
Deafness
Dementia
Depression
Disturbances in sweating
Dysphagia
Dyspnoea
Dysuria
Ecchymosis
Electrolyte disturbances
Elevation of liver enzymes
Eosinophilia
Epistaxis
Exfoliative dermatitis
Eye disorder
Fatigue
Febrile neutropenia
Fever
Flushing
Gastro-intestinal disturbances
Genitourinary disorder
Haematuria
Haemorrhage
Haemorrhagic cystitis
Headache
Hepatic damage
Hypaesthesia
Hyperglycaemia
Hypochromic anaemia
Immunosuppression
Increase in blood urea nitrogen
Increase in creatinine
Infections
Influenza-like syndrome
Insomnia
Joint disorder
Leucopenia
Lymphadenopathy
Malaise
Multiorgan failure
Myalgia
Myelosuppression
Nausea
Neoplasms
Nervous system effects
Neuropathy
Oedema
Oral ulceration
Pain
Pancytopenia
Paraesthesia
Petechiae
Photophobia
Photosensitivity
Pneumonia
Pruritus
Psychiatric disorders
Rash
Rectal disorders
Renal failure
Respiratory disorders
Seborrhoea
Shock
Skin disorder
Somnolence
Splenomegaly
Stevens-Johnson syndrome
Stomatitis
Taste disturbances
Thrombocytopenia
Tinnitus
Tremor
Tumour lysis syndrome
Urinary retention
Vesiculo-bullous reactions
Vomiting
Weight changes
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: December 2016
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Joint Formulary Committee. British National Formulary. 72nd ed. London: BMJ Group and Pharmaceutical Press; 2016.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Summary of Product Characteristics: Nipent 10 mg powder for injection. Hospira UK Ltd. Revised May 2016
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
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