BNF for Children (BNFC) 2018-2019

Scottish Medicines Consortium (SMC) Decisions

TheScottish Medicines Consortiumhas advised (October

2016 ) that pegaspargase (Oncaspar®) is accepted for use

within NHS Scotland as a component of antineoplastic

combination therapy in acute lymphoblastic leukaemia.

lMEDICINAL FORMS

There can be variation in the licensing of different medicines

containing the same drug.

Solution for injection

▶Oncaspar (Imported (United States))A

Pegaspargase 750 unit per 1 mlOncaspar 3 , 750 units/ 5 ml solution

for injection vials| 1 vialPs

Procarbazine

lDRUG ACTIONProcarbazine is a mild monoamine-oxidase

inhibitor.

lINDICATIONS AND DOSE

Hodgkin’s lymphoma

▶BY MOUTH

▶Child:(consult local protocol)

IMPORTANT SAFETY INFORMATION

RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES

See Cytotoxic drugs p. 531.

lCONTRA-INDICATIONSPre-existing severe leucopenia.

pre-existing severe thrombocytopenia

lCAUTIONSCardiovascular disease.cerebrovascular disease

.epilepsy.phaeochromocytoma.procarbazine is a mild

monoamineoxidase inhibitor (dietary restriction is rarely

considered necessary)

lINTERACTIONS→Appendix 1 : procarbazine

lSIDE-EFFECTS

▶Common or very commonAppetite decreased

▶Frequency not knownAzoospermia.hepatic disorders.

infection.lethargy.leucopenia.nausea.neutropenia.

ovarian failure.pneumonitis.skin reactions.

thrombocytopenia.vomiting

lCONCEPTION AND CONTRACEPTIONContraceptive advice

required, seePregnancy and reproductive functionin

Cytotoxic drugs p. 531.

lPREGNANCYAvoid (teratogenic inanimalstudies and

isolated reports in humans). See alsoPregnancy and

reproductive functionin Cytotoxic drugs p. 531.

lBREAST FEEDINGDiscontinue breast-feeding.

lHEPATIC IMPAIRMENTCaution in mild to moderate

impairment. Avoid in severe impairment.

lRENAL IMPAIRMENTCaution in mild to moderate

impairment. Avoid in severe impairment.

lMEDICINAL FORMS

There can be variation in the licensing of different medicines

containing the same drug.

Capsule

CAUTIONARY AND ADVISORY LABELS 4

▶Procarbazine (Non-proprietary)

Procarbazine (as Procarbazine hydrochloride)

50 mgProcarbazine 50 mg capsules| 50 capsuleP£ 411. 34 –

£ 411. 35 DT = £ 411. 35

RETINOID AND RELATED DRUGS

Tretinoin

lINDICATIONS AND DOSE

Induction of remission in acute promyelocytic leukaemia

(used in previously untreated patients as well as in those

who have relapsed after standard chemotherapy or who

are refractory to it)

▶BY MOUTH

▶Child:(consult local protocol)

lCAUTIONSIncreased risk of thromboembolism duringfirst

month of treatment

lINTERACTIONS→Appendix 1 : retinoids

lSIDE-EFFECTS

▶Common or very commonAbdominal pain.alopecia.

anxiety.appetite decreased.arrhythmia.asthma.bone

pain.cheilitis.chest pain.chills.confusion.constipation

.depression.diarrhoea.dizziness.dry mouth.flushing.

headache.hearing impairment.hyperhidrosis.idiopathic

intracranial hypertension (children particularly

susceptible—consider dose reduction if intractable

headache).insomnia.intracranial pressure increased.

malaise.nasal dryness.nausea.pancreatitis.paraesthesia

.respiratory disorders.skin reactions.visual impairment.

vomiting

▶Frequency not knownEmbolism and thrombosis.erythema

nodosum.genital ulceration.hepatotoxicity.

hypercalcaemia.increased leucocytes.myocardial

infarction.myositis.necrotising fasciitis.QT interval

prolongation.stroke.thrombocytosis.vasculitis

SIDE-EFFECTS, FURTHER INFORMATIONChildren are

particulary susceptible to nervous system effects.

Retinoic acid syndromeFever, dyspnoea, acute

respiratory distress, pulmonary infiltrates, pleural

effusion, hyperleucocytosis, hypotension, oedema, weight

gain, hepatic, renal and multi-organ failure requires

immediate treatment—consult product literature.

lCONCEPTION AND CONTRACEPTIONEffective

contraception must be used for at least 1 month before

oral treatment, during treatment and for at least 1 month

after stopping (oral progestogen-only contraceptives not

considered effective).

lPREGNANCYTeratogenic. SeePregnancy and reproductive

functionin Cytotoxic drugs p. 531.

lBREAST FEEDINGAvoid (discontinue breast-feeding).

lHEPATIC IMPAIRMENT

Dose adjustmentsReduce dose—consult local treatment

protocol for details.

lRENAL IMPAIRMENT

Dose adjustmentsReduce dose—consult local treatment

protocol for details.

lMONITORING REQUIREMENTSMonitor haematological and

coagulation profile, liver function, serum calcium and

plasma lipids before and during treatment.

lPRESCRIBING AND DISPENSING INFORMATIONTretinoin is

the acid form of vitamin A.

lMEDICINAL FORMS

There can be variation in the licensing of different medicines

containing the same drug.

Capsule

CAUTIONARY AND ADVISORY LABELS21, 25

▶Tretinoin (Non-proprietary)

Tretinoin 10 mgTretinoin 10 mg capsules| 100 capsuleP

£ 240. 00 – £ 256. 80 DT = £ 240. 00

554 Cytotoxic responsive malignancy BNFC 2018 – 2019

Immune system and malignant disease

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