Daunorubicin

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Daunorubicin hydrochloride 2.14 mg/mL equivalent to daunorubicin 2 mg/mL
Available from:
Pfizer New Zealand Limited
INN (International Name):
Daunorubicin hydrochloride 2.14 mg/mL (equivalent to daunorubicin 2 mg/mL)
Dosage:
2 mg/mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Daunorubicin hydrochloride 2.14 mg/mL equivalent to daunorubicin 2 mg/mL Excipient: Sodium chloride Water for injection
Units in package:
Vial, plastic, 10 mL PP with halobutyl rubber stopper, crimp cap and plastic flip-off lid, 1 dose unit
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Meiji Seika Kaisha Ltd
Therapeutic indications:
Daunorubicin Injection is indicated for the treatment of the following: · Acute lymphocytic (lymphoblastic) leukaemia: Daunorubicin is usually reserved for use in cases shown to be resistant to other drugs. However, combined treatment with daunorubicin, vincristine and a steroid has been used in the early stages of this disease.
Product summary:
Package - Contents - Shelf Life: Vial, plastic, 10 mL PP with halobutyl rubber stopper, crimp cap and plastic flip-off lid - 1 dose units - 2 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
Authorization number:
TT50-8767
Authorization date:
2011-02-24

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NEW ZEALAND DATA SHEET

1.

PRODUCT NAME

Daunorubicin 2 mg/mL solution for injection

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Daunorubicin

Injection

sterile,

isotonic,

preservative

free

solution

containing

daunorubicin hydrochloride 2.14 mg/mL (equivalent to 2 mg/mL daunorubicin).

Daunorubicin hydrochloride occurs as a hygroscopic, crystalline, orange-red powder, freely

soluble in water and in methanol, slightly soluble in alcohol and practically insoluble in

acetone.

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Solution for injection

4.

CLINICAL PARTICULARS

4.1 Therapeutic indications

Daunorubicin Injection is indicated for the treatment of the following:

Acute lymphocytic (lymphoblastic) leukaemia: Daunorubicin is usually reserved for use

in cases shown to be resistant to other drugs. However, combined treatment with

daunorubicin, vincristine and a steroid has been used in the early stages of this disease.

Acute myeloblastic leukaemia: Daunorubicin has been used in all stages, alone or in

combination with other cytotoxic agents (e.g. cytarabine).

Disseminated solid tumours: Daunorubicin has been investigated for use in these

tumours and found to be effective in some cases of disseminated neuroblastoma and

rhabdomyosarcoma.

4.2 Dose and method of administration

Daunorubicin Injection is intended for intravenous use only and should not be administered

by either the intramuscular or the subcutaneous routes, as severe tissue necrosis will result.

Daunorubicin must be given into a rapidly flowing intravenous infusion.

Dose

The dosage of each individual injection may vary from 0.5 to 3 mg/kg, with the frequency of

repetition according to the dose:

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0.5 to 1 mg/kg repeated at intervals of one or more days;

2 mg/kg repeated at intervals of four or more days;

2.5 or 3 mg/kg, if used, should only be given at seven to fourteen day intervals.

Dosage must be adjusted to meet individual requirements of each patient, on the basis of

clinical response and appearance or severity of toxicity. One injection has sometimes

sufficed;

commonly

three

injections

have

been

necessary;

occasionally

10 injections in one series have been used.

When second or subsequent injections are to be given the doses and the time intervals depend

effect

previous

doses

must

subject

careful

deliberation,

examination of the peripheral blood and under some circumstances, of the marrow.

In acute lymphocytic leukaemia, doses of 1 mg/kg may be repeated according to tolerance

and effect at one to four day intervals.

In acute myeloblastic leukaemia, each dose should be about 2 mg/kg, more or less, according

to effect, repeated at four to seven day intervals. Doses of over 2 mg/kg should be employed

with caution at intervals of one week or longer.

When daunorubicin is administered with other cytotoxic drugs, which have a tendency to

depress the marrow, the dosage should be suitably reduced. Examples of combination dosage

regimens are as follows:

Acute lymphocytic leukaemia: Prednisolone 100 mg/m

daily with vincristine 1.5 mg/m

the first and second days of each week, until remission occurs.

Acute myeloblastic leukaemia: Repeated intermittent courses of daunorubicin and cytosine

arabinoside,

each

course

consisting

intravenous

injection

both

daunorubicin

1.5 mg/kg and cytarabine 2 mg/kg on the first day, followed by daily cytarabine only for a

further four days. It has been reported that an average of two to three such courses at ten day

intervals is required to induce remission.

Due to cardiotoxicity, the total lifetime dosage should not exceed 20 mg/kg (see section 4.4,

Cardiac Toxicity). The drug is therefore not suitable for maintenance therapy.

Dose Adjustments

Hepatic impairment

Daunorubicin should not be administered to patients with severe hepatic impairment (Child-

Pugh Grade C [total score 10-15]) (see section 4.3).

For patients with mild and moderate hepatic impairment (Child-Pugh Grade A [total score 5-

6] and B [total score 7-9]), dose reductions are recommended based on the following serum

bilirubin values:

Bilirubin 1.2 to 3 mg/dL: one-half of recommended starting dose

Bilirubin > 3 mg/dL: one-fourth of recommended starting dose

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Renal impairment

Daunorubicin should not be administered to patients with severe renal function impairment

(GFR <10 mL/min or serum creatinine >7.9 mg/dL) (see section 4.3).

For patients with moderate renal impairment, glomerular filtration rate (GFR) between 10-20

mL/min or serum creatinine approximately between 3.4-7.9 mg/dL, the daunorubicin dose

should be reduced by one-half.

Method of Administration

It is recommended the injection be added to a free flowing IV infusion of 0.9% sodium

chloride or 5% dextrose injection. The tubing should be connected to a butterfly needle,

inserted preferably into a large vein. The dose and the size of the vein will determine the rate

of administration, which should not be less than 3-5 minutes. Erythematous streaking and

facial flushing are indications of too rapid administration.

A direct push injection is not recommended due to the risk of extravasation, which may occur

even in the presence of adequate blood return upon needle aspiration.

Instructions to be Given to Patients

Patients should be advised to immediately report any stinging or burning as these indicate

possible extravasations. If this occurs the infusion should be stopped, removed and restarted

in another vein.

Daunorubicin may transiently impart a red discolouration to the urine after administration;

patients should be advised to expect this.

Complete alopecia is common but reversible on withdrawal of treatment. Patients should be

made aware of this adverse effect before commencement of treatment.

Due to the increased frequency of infection as well as haemorrhagic complications resulting

from daunorubicin therapy, the patient should be instructed to notify the doctor if fever, sore

throat, or unusual bleeding or bruising occurs.

4.3 Contraindications

Daunorubicin Injection is contraindicated in:

Patients with persistent myelosuppression; or marked myelosuppression induced by

previous treatment with other cytotoxic agents or radiotherapy.

Patients with impaired

cardiac function (including myocardial insufficiency, recent

myocardial infarction and severe arrhythmias).

Patients who have previously received the full cumulative dose of daunorubicin and/or

doxorubicin. and/or other anthracyclines and/or anthracenediones (see section 4.4).

Patients with known hypersensitivity to daunorubicin. or any other component of the

product, other anthracyclines, or anthracenediones.

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Patients with severe infections.

Patients with severe hepatic (Child-Pugh Grade C [total score 10-15]) or renal function

impairment (GFR <10 mL/min or serum creatinine >7.9 mg/dL).

Patients who are pregnant.

4.4 Special warnings and precautions for use

Daunorubicin should be administered only under the supervision of a physician who is

experienced in the use of cancer chemotherapeutic agents.

Initial treatment with daunorubicin requires close observation of the patient and extensive

laboratory monitoring. It is recommended, therefore, that patients be hospitalised at least

during the first phase of treatment. Blood counts and monitoring of parameters of renal and

liver function should be performed prior to each treatment with daunorubicin.

Administration of myelosuppressive drugs such as daunorubicin may lead to an increased

frequency of infections and haemorrhagic complications. These complications are potentially

fatal therefore patients should be instructed to notify the physician if fever, sore throat, or

unusual bruising or bleeding occurs.

Patients should recover from acute toxicities of prior cytotoxic treatment (such as stomatitis,

neutropenia, thrombocytopenia, and generalised infections) before beginning treatment with

daunorubicin

Cardiac Toxicity

Special attention must be given (by close cardiac monitoring) to the cardiac toxicity exhibited

by daunorubicin, especially in infants and children.

Daunorubicin has a cardiotoxic effect, which can be manifested under two distinct sets of

circumstances:

Firstly, daily administration of large doses (of ≥2 mg/kg(or ≥55 mg/m

)) will result in

transient reversible electrocardiogram ECG changes in a proportion of cases. This can be

avoided by administering the drug at longer intervals.

Secondly, exceeding the total cumulative dose of 20 mg/kg (or 550 mg/m

) may result in

irreversible cardiac failure. This can occur with very little warning and after only a short

period of tachycardia.

Cardiomyopathy usually appears within 1 to 6 months after initiation of therapy. It may

develop suddenly and may not be detected by routine ECG. It may be irreversible and fatal

but responds to treatment if detected early.

Acute and Delayed Cardiotoxicity

Cardiotoxicity may be manifested by early (i.e. acute) or late (i.e. delayed) events.

Early (i.e. acute) events: Early cardiotoxicity of daunorubicin consists mainly of sinus

tachycardia

and/or

abnormalities

such

non-specific

ST-T

wave

changes.

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Tachyarrhythmias, including premature ventricular contractions, as well as heart block have

also been reported. These effects do not usually predict subsequent development of delayed

cardiotoxicity, are rarely of clinical importance, and are generally not a consideration for

discontinuation of daunorubicin treatment.

Late (i.e. delayed) events: Delayed cardiotoxicity usually develops late in the course of

therapy with daunorubicin or within 2 to 3 months after treatment termination, but later

events (several months to years after completion of treatment) have also been reported.

Delayed cardiomyopathy is manifested by reduced left ventricular ejection fraction (LVEF)

and/or signs and symptoms of congestive heart failure (CHF) such as dyspnoea, pulmonary

oedema,

dependent

oedema,

cardiomegaly

hepatomegaly,

oliguria,

ascites,

pleural

effusion, and gallop rhythm. Life-threatening CHF is the most severe form of anthracycline-

induced cardiomyopathy and represents the cumulative dose-limiting toxicity of the drug.

Risk Factors for Cardiotoxicity

There is increased risk of cardiac toxicity (and lower cumulative dosage limit) in patients

previously treated with doxorubicin or in those who received prior or concomitant radiation

therapy that encompassed the heart (mediastinal/pericardial area).

Pre-existing active or dormant heart disease, concomitant use of drugs with the ability to

suppress

cardiac

contractility

previous

therapy

with

other

anthracyclines

anthracenediones are suspected co-factors of increased risk of daunorubicin-induced cardiac

toxicity.

probable

that

toxicity

daunorubicin

other

anthracyclines

anthracenediones is additive.

Anthracyclines including daunorubicin should not be administered in combination with other

cardiotoxic

agents

(e.g.

trastuzumab)

unless

patient’s

cardiac

function

closely

monitored. Patients receiving anthracyclines after stopping treatment with other cardiotoxic

agents, especially those with long half-lives such as trastuzumab (variable half-life; washout

period up to 7 months), may also be at an increased risk of developing cardiotoxicity. Under

these conditions, a total cumulative dose of 400 mg/m

in adults should be exceeded only

with extreme caution.

It has also been suggested, but is not clearly established, that concurrent therapy with

cyclophosphamide or some other antineoplastic agents (e.g. dacarbazine, dactinomycin,

mitomycin) may increase the risk of daunorubicin-induced cardiotoxicity.

Cardiac function must be carefully monitored in all patients receiving high cumulative doses

and in those with risk factors. However, cardiotoxicity with daunorubicin may occur at lower

cumulative doses whether or not cardiac risk factors are present.

In infants and children there appears to be a greater susceptibility to anthracycline-induced

cardiac toxicity, and a long-term periodic evaluation of cardiac function has to be performed.

Total Cumulative Dosage

The incidence of cardiotoxicity is more frequent in adults receiving a total cumulative dose

over 550 mg/m

(or over 20 mg/kg body weight) or over 400 mg/m

in patients who have

received concurrent cyclophosphamide or previous chest irradiation, in the elderly, and in

patients with a history of cardiac disease or mediastinal radiation. In adults, at total

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cumulative

doses

less

than

550 mg/m

acute

congestive

cardiac

failure

seldom

encountered, although rare instances of pericarditis-myocarditis, not dose related, have been

reported.

Children may be more susceptible to the development of cardiomyopathy than adults.

However the risk of developing cardiomyopathy is reduced with a total dose less than

300 mg/m

in children over 2 years of age or at a total dosage of less than 10 mg/kg in

children younger than 2 years of age with a body surface area of less than 0.5 m

Monitoring of Cardiac Function

Cardiac function should be assessed before patients undergo treatment with daunorubicin and

must be monitored throughout therapy to minimise the risk of incurring severe cardiac

impairment. There is no absolutely reliable method of predicting the patients in whom acute

congestive heart failure will develop as a result of daunorubicin therapy. However, certain

changes in the ECG and a decrease in the left ventricular ejection fraction (LVEF) from pre-

treatment baseline may help to recognise those patients at greatest risk. On the basis of the

ECG, a decrease equal to or greater than 30% in limb lead QRS voltage has been associated

with a significant risk of drug-induced cardiomyopathy. The appropriate quantitative method

for repeated evaluation of LVEF includes multi-gated radionuclide angiography (MUGA) or

echocardiography (ECHO).

A baseline cardiac evaluation with an ECG and either a MUGA scan or an ECHO is

recommended, especially in patients with risk factors for increased cardiotoxicity. Repeated

MUGA or ECHO determinations of LVEF should be performed, particularly with higher,

cumulative anthracycline doses. The technique used for assessment should be consistent

throughout

follow-up.

risk

cardiotoxicity

decreased

through

regular

monitoring

LVEF

during

course

treatment

with

prompt

discontinuation

daunorubicin at the first sign of impaired cardiac function. Early clinical diagnosis of drug-

induced congestive heart failure appears to be essential for successful treatment with digoxin,

diuretics, sodium restriction and bed rest.

Bone Marrow Depression

Bone marrow depression and consequent marked cytopenia will occur in all patients who

receive daunorubicin and requires careful monitoring. The severity being dependent on the

dose received and the regenerative capacity of the bone marrow. Evaluation of response

based on bone marrow status cellularity is necessary to guide daunorubicin treatment.

Myelosuppression is manifested primarily by

leucopenia, which is usually severe, and

thrombocytopenia. Anaemia may also occur. Leucocyte and platelet nadirs usually occur

around days 10-14, with recovery around day 21 following therapy.

Haematologic

profiles

must

carefully

assessed

before

during

each

cycle

daunorubicin therapy, including differential white blood cell counts.

Clinical

consequences

severe

myelosuppression

include

fever,

infection,

sepsis/septicaemia, septic shock, haemorrhage, tissue hypoxia, or death. During a course of

therapy special attention should be devoted to patients with severe neutropenia and fever

(febrile neutropenia), a condition that can be possibly followed by septicaemia and death.

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In a variable proportion of cases, a severe aplasia will develop which must be anticipated in

every case by eliminating infection before treatment, by isolating the patient from infection

during

treatment

supportive

therapy,

including

continuous

administration of anti-infective agents, the administration of platelet rich plasma or fresh

whole blood transfusion and, under some circumstances, the transfusion of blood or white

cells from cases of hyperleucocytic chronic myeloid leukaemia. Therapy with daunorubicin

should not be started in patients with pre-existing drug-induced bone marrow depression

unless the benefit from such treatment warrants the risk.

Secondary Leukaemia

Secondary leukaemia, with or without a preleukemic phase, has been reported in patients

treated with anthracyclines, including daunorubicin. Secondary leukaemia is more common

when such drugs are given in combination with DNA-damaging antineoplastic agents, in

combination with radiotherapy, when patients have been heavily pre-treated with cytotoxic

drugs, or when doses of the anthracyclines have been escalated. These leukemias can have a

1- to 3-year latency period.

Immunosuppression/Increased Susceptibility to Infections

Daunorubicin possesses immunosuppressive properties. Appropriate measures should be

taken to prevent secondary infection.

Administration

live

live-attenuated

vaccines

patients

immunocompromised

chemotherapeutic agents including daunorubicin, may result in serious or fatal infections.

Vaccination with a live vaccine should be avoided in patients receiving daunorubicin. Killed

or inactivated vaccines may be administered; however, the response to such vaccines may be

diminished (see section 4.5).

Enhanced Toxicity

Daunorubicin

enhance

toxicity

other

cytotoxic

agents

when

administered

concurrently and dosage should be suitably reduced (see section 4.5).

Gastrointestinal Effects

Nausea and vomiting are usually mild and transient, occurring soon after administration and

lasting 24 to 48 hours. Severe nausea and vomiting may produce dehydration. Nausea and

vomiting may be prevented or alleviated by the administration of appropriate antiemetic

therapy.

Mucositis (mainly stomatitis, less often oesophagitis) may occur in patients undergoing

daunorubicin therapy. Mucositis/stomatitis generally appear early after drug administration

(burning and erythema of the oral mucosa; sores in the mouth and/or lips occurring 3 to 7

days after administration) and if severe, may progress over a few days to mucosal ulcerations

(7 to 10 days after administration). Most patients recover from this adverse event by the third

week of therapy.

Renal Impairment

Renal impairment can enhance the toxicity of recommended doses of daunorubicin. Prior to

administration, it is recommended that renal function be evaluated using conventional clinical

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laboratory tests. Dosage should be reduced

in patients with impaired renal

function.

(see sections 4.3 and 4.2).

Daunorubicin has been implicated as causing renal failure and should therefore be used with

caution when renal damage exists.

Hepatic Impairment

Hepatotoxic effects have been reported resulting from daunorubicin treatment. Care should

therefore be exercised when treating patients with impaired liver function.

The major route of elimination of daunorubicin is the hepatobiliary system. Serum total

bilirubin should be evaluated before and during treatment with daunorubicin. Patients with

elevated bilirubin may experience slower clearance of drug with an increase in overall

toxicity. Lower doses are recommended in these patients (see section 4.2).

Patients with severe hepatic impairment must not receive daunorubicin (see section 4.3).

Effects at Site of Injection

Phlebosclerosis may result from an injection into a small vessel or from repeated injections

into the same vein. Following the recommended administration procedures may minimise the

risk of phlebitis/thrombophlebitis at the injection site (see section 4.2).

Extravasation

Extravasation of daunorubicin at the site of intravenous administration can cause local pain,

severe tissue lesions (vesication, severe cellulitis) and necrosis. Should signs or symptoms of

extravasation occur during intravenous administration of daunorubicin, the drug infusion

should be immediately stopped.

Hyperuricaemia/Tumour Lysis Syndrome

Daunorubicin

induce

hyperuricaemia

consequence

extensive

purine

catabolism that accompanies rapid drug-induced destruction of a large number of leukaemia

cells (tumour-lysis syndrome).

It is recommended to check the blood uric acid urea potassium, calcium phosphate and

creatinine levels, three or four times a week during the first week of treatment, Hydration,

urine alkalinisation and prophylaxis with allopurinol to prevent hyperuricemia may minimise

potential complications of tumor-lysis syndrome.

Neurotoxic Effects

There is little evidence of neurotoxic effects.

Alopecia

Complete alopecia involving beard growth and the scalp, axillary and pubic hair occurs

almost always with full doses of daunorubicin. This side-effect may cause distress to patients

but is usually reversible, with regrowth of hair, which usually occurs within two to three

months from the termination of therapy.

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Radiotherapy

Increased radiation toxicities such as skin reactions and mucositis may result from concurrent

radiotherapy and daunorubicin therapy.

4.5 Interaction with other medicines and other forms of interaction

Daunorubicin is mainly used in combination with other cytotoxic drugs. Additive toxicity

may occur especially with regard to bone marrow/haematologic and gastrointestinal effects

(see section

4.4).

daunorubicin

combination

chemotherapy

with

other

potentially cardiotoxic drugs as well as the concomitant use of other cardioactive compounds

(e.g. calcium channel blockers) requires monitoring of cardiac function throughout treatment.

Changes

hepatic

renal

function

induced

concomitant

therapies

affect

daunorubicin metabolism, pharmacokinetics, therapeutic efficacy and/or toxicity.

Cyclophosphamide

The cardiotoxic effects of daunorubicin may be enhanced by concurrent treatment with

cyclophosphamide. Daunorubicin may exacerbate cyclophosphamide induced haemorrhagic

cystitis. It is recommended that the total dose of daunorubicin not exceed 400 mg/m

of body

surface area when administered concurrently with cyclophosphamide.

Doxorubicin

Previous

treatment

with

doxorubicin

increases

risk

daunorubicin

induced

cardiotoxicity. Daunorubicin should not be administered to patients who have received the

complete cumulative dose of doxorubicin.

Allopurinol, Colchicine, Probenecid or Sulphinpyrazone

Daunorubicin

raise

concentration

uric

acid

blood.

Control

hyperuricaemia

gout

require

dosage

adjustments

made

antigout

medications

better

control.

Allopurinol

preferred

prevent

reverse

daunorubicin induced hyperuricaemia because of the risk of uric acid nephropathy with

uricosuric antigout agents.

Other Bone Marrow Depressants

Reduced dosage of daunorubicin may be required.

Hepatotoxic Medications

Concurrent administration may increase the risk of hepatotoxicity.

Live Virus Vaccines

Due to its immunosuppressive properties, concurrent use of daunorubicin with a live virus

vaccine may potentiate the replication of the vaccine, increase the adverse effects of the

vaccine virus, or decrease the patient’s antibody response to the virus.

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4.6 Fertility, pregnancy and lactation

Pregnancy - Category D

Daunorubicin has shown teratogenic, mutagenic and carcinogenic potential in animals. The

drug must be considered as a potential cause of foetal malformations when administered to a

pregnant woman. Daunorubicin should not be used during pregnancy (see section 4.3).

Daunorubicin should only be used in women of childbearing potential if the expected benefits

outweigh the risks of therapy and adequate contraception is used. If the patient becomes

pregnant whilst receiving the drug she should be advised of the potential hazard to the foetus.

Category D: Drugs that have caused, are suspected to have caused - or may be expected to

cause - an increased incidence of human foetal malformations or irreversible damage. These

drugs may also have adverse pharmacological effects.

Breast-feeding

It is not known whether daunorubicin is excreted in breast milk therefore breastfeeding is not

recommended during daunorubicin therapy in lactating women. It is recommended that

daunorubicin is not administered to mothers who are breastfeeding.

Fertility

Daunorubicin, could induce chromosomal damage in human spermatozoa. Men undergoing

treatment with daunorubicin should use effective contraceptive methods.

4.7 Effects on ability to drive and use machinery

No data available.

4.8 Undesirable effects

The adverse effects are listed by system organ class and frequency category. Frequency

categories are defined as: very common (

1/10), common (

1/100 to <1/10), uncommon

1/1,000 to <1/100), rare (

1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot

be estimated from the available data) (see section 4.4).

System Organ Class

Frequency

Adverse Effects

Infections and Infestations

Very common

Sepsis/septicemia; infection

Not known

Septic shock

Neoplasms Benign,

Malignant and Unspecified

(including cysts and polyps)

Uncommon

Acute myeloid leukemia

Not known

Myelodysplastic syndrome

Blood and Lymphatic

System Disorders

Very common

Bone marrow failure; leukopenia;

granulocytopenia; neutropenia;

thrombocytopenia; anemia

Immune System Disorders

Not known

Anaphylactic reaction/anaphylactoid

reaction

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