What is Aubagio and what is it used for?
Aubagio is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS). Aubagio can decrease the number of MS flare-ups (relapses). Aubagio does not cure MS, but it can help slow down the physical problems that MS causes.
It is not known if Aubagio is safe and effective in children.
Who should not take Aubagio?
Do not take Aubagio if you:
- have had an allergic reaction to Aubagio or a medicine called leflunomide
- have severe liver problems
- are pregnant or are of childbearing age and not using effective birth control
- take a medicine called leflunomide
What are the side effects of Aubagio?
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.
Concomitant use of Aubagio with other potentially hepatotoxic drugs may increase the risk of severe liver injury.
Obtain transaminase and bilirubin levels within 6 months before initiation of Aubagio therapy. Monitor ALT levels at least monthly for six months after starting Aubagio. If drug induced liver injury is suspected, discontinue Aubagio and start an accelerated elimination procedure with cholestyramine or charcoal. Aubagio is contraindicated in patients with severe hepatic impairment. Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking Aubagio.
Risk of Teratogenicity
Aubagio is contraindicated for use in pregnant women and in women of reproductive potential who are not using effective contraception because of the potential for fetal harm. Teratogenicity and embryolethality occurred in animals at plasma teriflunomide exposures lower than that in humans. Exclude pregnancy before the start of treatment with Aubagio in females of reproductive potential. Advise females of reproductive potential to use effective contraception during Aubagio treatment and during an accelerated drug elimination procedure after Aubagio treatment. Stop Aubagio and use an accelerated drug elimination procedure if the patient becomes pregnant.
Aubagio (teriflunomide) is a pyrimidine synthesis inhibitor used to treat relapsing forms of multiple sclerosis (MS). Side effects of Aubagio include:
- liver problems,
- hair loss or thinning hair,
- burning or prickly feeling in your skin, or
- numbness or tingling in your hands or feet that is different from your MS symptoms.
Tell your doctor if you have serious side effects of Aubagio including:
- body aches,
- flu symptoms,
- sores in your mouth and throat,
- tired feeling,
- loss of appetite,
- dark urine,
- clay-colored stools,
- yellowing of the skin or eyes,
- fast or racing heartbeats,
- little or no urinating,
- chest pain,
- dry cough,
- feeling short of breath,
- skin redness or peeling,
- rapid weight gain, or
- severe skin reaction – fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
The recommended dose for Aubagio is 7 mg or 14 mg taken orally, once daily, with or without food. Aubagio may increase exposure of ethinyl estradiol and levonorgestrel. Patients taking Coumadin (warfarin) should be closely monitored as interactions may occur. Aubagio may cause major birth defects if used during pregnancy. Pregnancy must be excluded before starting treatment with Aubagio. Pregnancy must be avoided while taking Aubagio to treat relapsing forms of multiple sclerosis (MS). If Aubagio is used during pregnancy, or if the patient becomes pregnant while taking Aubagio, the drug should be discontinued immediately and an accelerated elimination procedure should be initiated. Consult your doctor before breastfeeding.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage of Aubagio?
The recommended dose of Aubagio is 7 mg or 14 mg orally once daily. Aubagio can be taken with or without food.
What drugs interact with Aubagio?
Effect of Aubagio on CYP2C8 Substrates
Teriflunomide is an inhibitor of CYP2C8 in vivo. In patients taking Aubagio, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP2C8 as required.
Effect of Aubagio on Warfarin
Coadministration of Aubagio with warfarin requires close monitoring of the international normalized ratio (INR) because Aubagio may decrease peak INR by approximately 25%.
Effect of Aubagio on Oral Contraceptives
Aubagio may increase the systemic exposures of ethinylestradiol and levonorgestrel. Consideration should be given to the type or dose of contraceptives used in combination with Aubagio.
Effect of Aubagio on CYP1A2 Substrates
Teriflunomide may be a weak inducer of CYP1A2 in vivo. In patients taking Aubagio, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP1A2 as required.
Effect of Aubagio on Organic Anion Transporter 3 (OAT3) Substrates
Teriflunomide inhibits the activity of OAT3 in vivo. In patients taking Aubagio, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) which are OAT3 substrates as required.
Effect of Aubagio on BCRP And Organic Anion Transporting Polypeptide B1 And B3 (OATP1B1/1B3) Substrates
Teriflunomide inhibits the activity of BCRP and OATP1B1/1B3 in vivo. For a patient taking Aubagio, the dose of rosuvastatin should not exceed 10 mg once daily. For other substrates of BCRP (e.g., mitoxantrone) and drugs in the OATP family (e.g., methotrexate, rifampin), especially HMG-Co reductase inhibitors (e.g., atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin), consider reducing the dose of these drugs and monitor patients closely for signs and symptoms of increased exposures to the drugs while patients are taking Aubagio.
What kind of disease is multiple sclerosis?
Is Aubagio safe to use while pregnant or breastfeeding?
Aubagio is contraindicated for use in pregnant women and females of reproductive potential not using effective contraception because of the potential for fetal harm based on animal data. Human data are not available at this time to inform the presence or absence of drug-associated risk with the use of Aubagio during pregnancy.
In animal reproduction studies in rat and rabbits, oral administration of teriflunomide during organogenesis caused teratogenicity and embryolethality at plasma exposures (AUC) lower than that at the maximum human recommended dose (MHRD) of 14 mg/day.
In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. The background risk of major birth defects and miscarriage in the indicated population is unknown.
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Aubagio during pregnancy. Healthcare providers and patients are encouraged to report pregnancies by calling 1-800-745-4447, option 2.
It is not known whether this drug is excreted in human milk. Teriflunomide was detected in rat milk following a single oral dose.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Aubagio and any potential adverse effects on the breastfed infant from Aubagio or from the underlying maternal condition.