-
tretinoin (generic) -Roche Laboratories
tretinoin: Black Box Warnings
Appropriate Use
-
weigh benefit vs. known adverse effects; admin. only by physician
experienced in acute leukemia tx in adequate medical facility to manage
complications
Retinoic Acid-APL Syndrome
-
occurs in 1st month of tx, possible after 1st dose; occurs in 25% of
pts; incl. fever, dyspnea, acute resp. distress, weight gain, pulmonary
infiltrates on x-ray, pleural and pericardial effusion, edema, and
hepatic, renal, and multi-organ failure; may also incl. impaired
myocardial contractility, episodic hypotension, and leukocytosis; at
1st signs give dexamethasone 10mg IV q12h x3 days or until sx resolve;
cont. tretinoin tx in most pts, but may hold tx if mod-severe retinoic
acid-APL syndrome
Leukocytosis
-
rapidly evolving leukocytosis assoc. w/ high risk of life-threatening
complications occurs in 40% of pts, incr. risk if baseline WBC >5
x10^9/L; start high dose steroids immediately if retinoic acid-APL
syndrome signs/sx also present; addition of chemotx can decr. incidence
of retinoic acid-APL syndrome if baseline WBC >5 x10^9/L or baseline
leukopenia w/ rapid incr. in WBC count on tretinoin tx; see pkg insert
for chemo timing based on WBC count
Teratogen
-
high risk of severe fetal deformities; fully inform pregnant women or
those of child-bearing potential of fetal risk, contraception failure
risk, must use 2 reliable forms of contraception during and x1 month
after D/C tx; must have neg. pregnancy test <1wk prior to tx start,
or if unable to delay may start tx w/ 2 reliable forms of
contraception; cont. pregnancy testing and contraception counseling qmo
during tx
tretinoin: Adult Dosing
Dosage forms: 10chemotherapy
- uses, dosing may vary
- Info: for all uses, refer to institution protocols and pkg insert prior to prescribing; see pkg insert for toxicity-related dose adjustments
APL, remission induction
- 45 mg/m^2/day PO div bid
- Max: duration 90 days; Info: D/C 30 days after remission; for FAB class M3 (incl. M3 variant) APL refractory to or relapsed from anthracycline tx or if anthracyclines contraindicated
renal dosing
- not defined
hepatic dosing
- not defined
tretinoin: Peds Dosing
Dosage forms: 10chemotherapy
- uses, dosing may vary
- Info: for all uses, refer to institution protocols and pkg insert prior to prescribing; see pkg insert for toxicity-related dose adjustments
APL, remission induction
- >1 yo
- Dose: 45 mg/m^2/day PO div bid; Max: duration 90 days; Info: D/C 30 days after remission; for FAB class M3 (incl. M3 variant) APL refractory to or relapsed from anthracycline tx or if anthracyclines contraindicated
renal dosing
- not defined
hepatic dosing
- not defined
tretinoin: Contraindications/Cautions
- hypersens. to drug/class/compon.
- hypersens. to retinoids
- hypersens. to parabens
- caution in pediatric pts
tretinoin: Drug Interactions
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
tretinoin: Adverse Reactions
Serious Reactions
- leukocytosis, rapidly evolving
- RA-APL syndrome
- hemorrhage
- GI bleed
- DIC
- arrhythmia
- pneumonia
- renal insufficiency
- cerebral hemorrhage
- hepatosplenomegaly
- pseudotumor cerebri
- cardiac failure
- cardiomyopathy
- cerebellar edema
- CNS depression
- convulsions
- encephalopathy
- facial paralysis
- GI ulceration
- hemiplegia
- hepatitis
- MI
- myocarditis/pericarditis
- pulmonary HTN
- renal failure
- renal tubular necrosis
- stroke
- sepsis
- thrombocytosis (rare)
- thrombosis, venous/arterial
- vasculitis (rare)
- others: see pkg insert
Common Reactions
- headache
- fever
- weakness
- skin/mucous membrane dryness
- bone pain
- malaise
- shivering
- hemorrhage
- hypercholesterolemia
- hypertriglyceridemia
- infection
- nausea/vomiting
- rash
- peripheral edema
- elevated LFTs
- leukocytosis, rapidly evolving
- pain
- GI bleeding
- chest discomfort
- abdominal pain
- edema
- DIC
- GI disorders
- mucositis
- RA-APL syndrome
- arrhythmias
- diarrhea
- earache/ear fullness
- flushing
- weight changes
- dizziness
- incr. sweating
- pruritus
- visual disturbance
- others: see pkg insert
tretinoin: Safety Monitoring
-
Pregnancy:
D
- Lactation:
Unsafe
- Monitoring Parameters:
pregnancy test <1wk prior to tx start, then qmo; CBC, lipid panel, LFTs, PT/INR frequently
tretinoin: Pharmacology
- Metabolism: liver; CYP450: specific isozymes not defined
- Excretion: urine (63%), feces (31%); half-life: 0.5-2h
- Class:
Other Oncologics
- Mechanism Of Action
exact mechanism of action unknown; induces differentiation and decr. proliferation of APL cells (retinoid)tretinoin: Manufacturer/Pricing
- Manufacturer:
generic
- DEA/FDA: Rx
tretinoin: Patient Education
Patient education material for this drug is not currently available.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.
Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.
The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
tretinoin: Pill Pictures
This information is currently unavailable or not applicable for this drug.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of your healthcare professional. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you. You should consult your healthcare professional before taking any drug, changing your diet or commencing or discontinuing any course of treatment.
Substantial effort has been made to ensure that the information provided by Rx Drug News is accurate and up-to-date, but this information is not intended to cover all possible uses, precautions, or other considerations relating to the therapies covered.
Rx Drug News does not advocate or endorse the use of any drug or other therapy and does not diagnose patients.
Healthcare professionals should use their professional judgment in using this information, and this information should not be considered a substitute for the care and professional judgment provided by a licensed healthcare practitioner.
This information if provided on an "as is" basis, and Rx Drug News and its affiliates, agents and licensors assume no responsibility for any aspect of healthcare administered with the aid of this information or any other use of the information.
Copyright 1996-2006 Cerner Multum, Inc. Version: 5.05. Revision Date: 10/09/2007
Last Updated: 10/09/2007
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