AUBAGIO*
Manufacturer DetailsGENERIC*
USA AND CANADA
Compositions:
Teriflunomide - mg,
Teriflunomide - mg,
| Strength | Rate | Packing Style |
|---|---|---|
| mg | 0.00 | unit |
List of Related Indications:
- Treatment of adults with relapsing forms of multiple sclerosis
List Of Drugs:
- Teriflunomide- Aubagio- @- (Sep 2012) -Immunomodulator
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Drugs metabolized by CYP2C8 and OAT3 transporters:
Monitor patients because teriflunomide may increase exposure of these drugs
.
Teriflunomide may increase exposure of ethinylestradiol and levonorgestrel.
Choose an appropriate oral contraceptive
.
Drugs metabolized by CYP1A2:
Monitor patients because teriflunomide may decrease exposure of these drugs
.
Warfarin: Monitor INR as teriflunomide may decrease INR
.
Drugs metabolized by BCRP and OATP1B1/B3 transporters:
Monitor patients because teriflunomide may increase exposure of these drugs
.
Rosuvastatin: The dose of rosuvastatin should not exceed 10 mg once daily in
patients taking AUBAGIO
Indication:
AUBAGIO (teriflunomide) tablets, for oral use
Initial U.S. Approval: 2012
WARNING: HEPATOTOXICITY and RISK OF TERATOGENICITY
See full prescribing information for complete boxed warning
Hepatotoxicity Severe liver injury including fatal liver failure has been reported
in patients treated with leflunomide, which is indicated for rheumatoid arthritis.
A similar risk would be expected for teriflunomide because recommended
doses of teriflunomide and leflunomide result in a similar range of plasma
concentrations of teriflunomide.
Obtain transaminase and bilirubin levels within 6 months before initiation
of AUBAGIO and monitor ALT levels at least monthly for six months
If drug induced liver injury is suspected, discontinue AUBAGIO and start
accelerated elimination procedure
Risk of Teratogenicity Based on animal data, AUBAGIO may cause major
birth defects if used during pregnancy.
AUBAGIO is contraindicated in pregnant women or women of childbearing
potential who are not using reliable contraception.
Pregnancy must be avoided during AUBAGIO treatment.
RECENT MAJOR CHANGES
Warnings and Precautions (5) 10/2014
Drug Name- Aubagio
Active Ingredient - Teriflunomide
For treatment of adults with relasping forms of multiple sclerosis(MS)
Indication-
Treatment of adults with relapsing forms of multiple sclerosis(MS)
Approved by FDA on 12-9-2012 (Ref- FDA Approved List- 2012)
Adverse Reaction:
Most common adverse reactions (.10% and .2% greater than placebo):
headache, diarrhea, nausea, alopecia, increase in ALT
Contra-Indications:
CONTRAINDICATIONS
Severe hepatic impairment
Pregnancy
Current leflunomide treatment
WARNINGS AND PRECAUTIONS.
Elimination of AUBAGIO can be accelerated by administration of cholestyramine
or activated charcoal for 11 days
.
AUBAGIO may decrease WBC. A recent CBC should be available before starting
AUBAGIO. Monitor for signs and symptoms of infection.
Consider suspending treatment with AUBAGIO in case of serious infection.
Do not start AUBAGIO in patients with active infections
.
If patient develops symptoms consistent with peripheral neuropathy,
evaluate patient and consider discontinuing AUBAGIO
.
Stop AUBAGIO if patient develops Stevens-Johnson syndrome or toxic
epidermal necrolysis
.
AUBAGIO may increase blood pressure. Measure blood pressure at treatment
initiation and monitor blood pressure during treatment
Dosages/ Overdosage Etc:
Indication-
Treatment of adults with relapsing forms of multiple sclerosis(MS)
INDICATIONS AND USAGE
AUBAGIO is a pyrimidine synthesis inhibitor indicated for the treatment
of patients with relapsing forms of multiple sclerosis
DOSAGE AND ADMINISTRATION
7 mg or 14 mg orally once daily, with or without food.
DOSAGE FORMS AND STRENGTHS
7 mg and 14 mg film-coated tablets
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
A Medication Guide is required for distribution with AUBAGIO.
Hepatotoxicity
Inform patients that AUBAGIO may increase liver enzymes and that their liver enzymes
will be checked before starting AUBAGIO and for at least 6 months while they are
taking AUBAGIO.
Advise patients that they should contact their physician if they have any unexplained
nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine.
Importance of Preventing Pregnancy
Inform patients that based on animal studies, AUBAGIO may cause fetal harm.
Advise women of childbearing potential of the need for effective contraception
during AUBAGIO treatment and until completion of an accelerated elimination
procedure.
Advise them that an accelerated elimination procedure can be used at any time
after the discontinuation of AUBAGIO.
Instruct the patient that if she suspects or confirms pregnancy, she should
immediately inform her physician. Inform the patients that an AUBAGIO
pregnancy registry is available.
Instruct men who are taking AUBAGIO and wish to father a child to discontinue
AUBAGIO and use an accelerated elimination procedure.
Instruct men taking AUBAGIO who do not wish to father a child that they
and their female partners should use reliable contraception.
Availability of an Accelerated Elimination Procedure
Advise patients that AUBAGIO may stay in the blood for up to 2 years afte
the last dose and that an accelerated elimination procedure may be used
if needed.
Risk of Infections
Inform patients that they may develop a lowering of their white blood cell counts
and that their blood counts will be checked before starting AUBAGIO.
Inform patients that they may be more likely to get infections when taking
AUBAGIO and that they should contact their physician if they develop
symptoms of infection, particularly in case of fever.
Advise patients that the use of some vaccines should be avoided during
treatment with AUBAGIO and for at least 6 months after discontinuation.
Peripheral Neuropathy
Inform patients that they may develop peripheral neuropathy.
Advise patients that they should contact their physician if they develop
symptoms of peripheral neuropathy, such as numbness or tingling
of hands or feet.
Increased Blood Pressure
Inform patients that AUBAGIO may increase blood pressure.
Nursing Mothers
Inform patients that it is not known whether this drug is present in human milk.
Advise patients to discontinue breastfeeding or discontinue the drug.
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Teriflunomide, an immunomodulatory agent with anti-inflammatory properties,
inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved
in de novo pyrimidine synthesis. The exact mechanism by which teriflunomide
exerts its therapeutic effect in multiple sclerosis is unknown but may involve
a reduction in the number of activated lymphocytes in CNS.
2. Pharmacokinetics
Teriflunomide is the principal active metabolite of leflunomide and is responsible for
leflunomide’s activity in vivo. At recommended doses, teriflunomide and leflunomide
result in a similar range of plasma concentrations of teriflunomide.
Based on a population analysis of teriflunomide in healthy volunteers and MS patients,
median t1/2 was approximately 18 and 19 days after repeated doses of 7 mg and
14 mg respectively. It takes approximately 3 months respectively to reach
steady-state concentrations. The estimated AUC accumulation ratio is approximately
30 after repeated doses of 7 or 14 mg.
Absorption
Median time to reach maximum plasma concentrations is between 1 to 4 hours post-dose
following oral administration of teriflunomide.
Food does not have a clinically relevant effect on teriflunomide pharmacokinetics
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category X
Use contraindicated
Pregnancy Registry Although AUBAGIO is contraindicated in pregnancy, a pregnancy
registry has been established to monitor fetal outcomes of pregnant women exposed
to AUBAGIO.
Physicians are encouraged to enroll pregnant women in the AUBAGIO pregnancy registry,
or pregnant women may enroll themselves by calling 1-800-745-4447.
2. Nursing Mothers
Teriflunomide was detected in rat milk following a single oral dose of teriflunomide.
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk and because of the potential for
serious adverse reactions in nursing infants from AUBAGIO a decision should be
made whether to discontinue nursing or to discontinue the drug, taking into account
the importance of the drug to the mother.
3. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
4. Geriatric Use
Clinical studies of AUBAGIO did not include patients over 65 years old.
