Aubagio

Last updated on RxList: 5/12/2021
Aubagio Side Effects Center

What Is Aubagio?

Aubagio (teriflunomide) is a pyrimidine synthesis inhibitor used to treat relapsing forms of multiple sclerosis (MS).

What Are Side Effects of Aubagio?

Side effects of Aubagio include:

  • liver problems,
  • influenza,
  • hair loss or thinning hair,
  • nausea,
  • diarrhea,
  • 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:

  • fever,
  • chills,
  • body aches,
  • flu symptoms,
  • sores in your mouth and throat,
  • itching,
  • tired feeling,
  • loss of appetite,
  • dark urine,
  • clay-colored stools,
  • yellowing of the skin or eyes,
  • fast or racing heartbeats,
  • confusion,
  • little or no urinating,
  • chest pain,
  • dry cough,
  • wheezing,
  • feeling short of breath,
  • skin redness or peeling,
  • swelling,
  • 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.

Dosage for Aubagio

The recommended dose for Aubagio is 7 mg or 14 mg taken orally, once daily, with or without food.

What Drugs, Substances, or Supplements Interact with Aubagio?

Aubagio may increase exposure of ethinyl estradiol and levonorgestrel. Patients taking Coumadin (warfarin) should be closely monitored as interactions may occur.

Aubagio During Pregnancy and Breastfeeding

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 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.

Additional Information

Our Aubagio (teriflunomide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

QUESTION

What kind of disease is multiple sclerosis? See Answer
Aubagio Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Stop using teriflunomide and call your doctor at once if you have:

  • numbness or tingling in your hands or feet that feels different from your MS symptoms;
  • trouble breathing, new or worsening cough with or without fever;
  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting;
  • signs of infection--fever, chills, body aches, nausea, vomiting, feeling tired; or
  • liver problems--upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • headache;
  • nausea, diarrhea;
  • thinning hair; or
  • abnormal liver function tests.

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.

Read the entire detailed patient monograph for Aubagio (Teriflunomide Tablets)

SLIDESHOW

What Is Multiple Sclerosis? MS Symptoms, Causes, Diagnosis See Slideshow
Aubagio Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the prescribing information:

  • Hepatotoxicity [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
  • Bone Marrow Effects/Immunosuppression Potential/Infections [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
  • Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
  • Drug Reaction with Eosinophilia and Systemic Symptoms [see WARNINGS AND PRECAUTIONS]
  • Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS]
  • Increased Blood Pressure [see WARNINGS AND PRECAUTIONS]
  • Respiratory Effects [see WARNINGS AND PRECAUTIONS]
  • Pancreatitis in Pediatric Patients [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

A total of 2047 patients receiving AUBAGIO (7 mg or 14 mg once daily) constituted the safety population in the pooled analysis of placebo-controlled studies in patients with relapsing forms of multiple sclerosis; of these, 71% were female. The average age was 37 years.

Table 1 lists adverse reactions in placebo-controlled trials with rates that were at least 2% for AUBAGIO patients and also at least 2% above the rate in placebo patients. The most common were headache, an increase in ALT, diarrhea, alopecia, and nausea. The adverse reaction most commonly associated with discontinuation was an increase in ALT (3.3%, 2.6%, and 2.3% of all patients in the AUBAGIO 7 mg, AUBAGIO 14 mg, and placebo treatment arms, respectively).

Table 1: Adverse Reactions in Pooled Placebo-Controlled Studies in Patients with Relapsing Forms of Multiple Sclerosis

Adverse Reaction AUBAGIO
7 mg
(N=1045)
AUBAGIO
14 mg
(N=1002)
Placebo
(N=997)
Headache 18% 16% 15%
Increase in Alanine aminotransferase 13% 15% 9%
Diarrhea 13% 14% 8%
Alopecia 10% 13% 5%
Nausea 8% 11% 7%
Paresthesia 8% 9% 7%
Arthralgia 8% 6% 5%
Neutropenia 4% 6% 2%
Hypertension 3% 4% 2%

Cardiovascular Deaths

Four cardiovascular deaths, including three sudden deaths, and one myocardial infarction in a patient with a history of hyperlipidemia and hypertension were reported among approximately 2600 patients exposed to AUBAGIO in the premarketing database. These cardiovascular deaths occurred during uncontrolled extension studies, one to nine years after initiation of treatment. A relationship between AUBAGIO and cardiovascular death has not been established.

Acute Renal Failure

In placebo-controlled studies, creatinine values increased more than 100% over baseline in 8/1045 (0.8%) patients in the 7 mg AUBAGIO group and 6/1002 (0.6%) patients in the 14 mg AUBAGIO group versus 4/997 (0.4%) patients in the placebo group. These elevations were transient. Some elevations were accompanied by hyperkalemia. AUBAGIO may cause acute uric acid nephropathy with transient acute renal failure because AUBAGIO increases renal uric acid clearance.

Hypophosphatemia

In clinical trials, 18% of AUBAGIO-treated patients had hypophosphatemia with serum phosphorus levels of at least 0.6 mmol/L, compared to 7% of placebo-treated patients; 4% of AUBAGIO-treated patients had hypophosphatemia with serum phosphorus levels at least 0.3 mmol/L but less than 0.6 mmol/L, compared to 0.8% of placebo-treated patients. No patient in any treatment group had a serum phosphorus below 0.3 mmol/L.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of AUBAGIO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Blood and Lymphatic System Disorders: Thrombocytopenia [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Disorders: Pancreatitis, colitis
  • Hepatobiliary Disorders: Drug-induced liver injury (DILI) [see WARNINGS AND PRECAUTIONS]
  • Immune System Disorders: Hypersensitivity reactions, some of which were severe, such as anaphylaxis and angioedema [see WARNINGS AND PRECAUTIONS]
  • Respiratory, Thoracic, and Mediastinal Disorders: Interstitial lung disease [see WARNINGS AND PRECAUTIONS]
  • Skin and Subcutaneous Tissue Disorders: Severe skin reactions, including toxic epidermal necrolysis and Stevens-Johnson syndrome [see WARNINGS AND PRECAUTIONS]; drug reaction with eosinophilia and systemic symptoms (DRESS) [see WARNINGS AND PRECAUTIONS]; psoriasis or worsening of psoriasis (including pustular psoriasis and nail psoriasis); nail disorders

DRUG INTERACTIONS

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 [see CLINICAL PHARMACOLOGY].

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 [see CLINICAL PHARMACOLOGY].

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 [see CLINICAL PHARMACOLOGY].

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 [see CLINICAL PHARMACOLOGY].

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 [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Aubagio (Teriflunomide Tablets)

© Aubagio Patient Information is supplied by Cerner Multum, Inc. and Aubagio Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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