Aubagio – Safety & Side Effects

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The most common side effects or adverse effects that occurred with Aubagio in placebo-controlled clinical trials involving 1,086 people with relapsing forms of MS included increased alanine transaminase (ALT), alopecia (loss of hair), diarrhea, influenza, nausea, and paresthesia (abnormal sensation, including burning, tingling, and pricking). Percentages of people who experienced these and other adverse effects while receiving Aubagio and placebo are shown in the table below.

Adverse effects in a study of Aubagio in MS

Adverse effect

Placebo (n=360)

Aubagio 7 mg (n=368)

Aubagio 14 mg (n=358)

Headache 18% 22% 19%
Diarrhea 9% 15% 18%
Nausea 7% 9% 14%
Increased alanine aminotransferase (ALT) 7% 12% 14%
Alopecia 3% 10% 13%
Influenza 10% 9% 12%
Paresthesia 8% 9% 10%
Upper respiratory tract infection 7% 9% 9%
Bronchitis 6% 5% 8%
Serious adverse effects with Aubagio included hepatotoxicity, infections, bone marrow suppression, immunosuppression, peripheral neuropathy, kidney failure, hyperkalemia, skin reactions, blood pressure changes, and respiratory effects.

 

Warnings and precautions

There are several warnings and precautions to be aware of if you are considering taking Aubagio.

Liver injury. Severe liver injury has occurred in some people who have used a drug that is similar to Aubagio called Arava (leflunomide). Arava is a disease-modifying drug used to treat rheumatoid arthritis. It is reasonable to assume that the risk for liver damage with Arava is similar with Aubagio. Aubagio should not be used in people with severe liver function impairment. In some people, Aubagio can cause increases in alanine transaminase (ALT) which indicates decreased liver function.

Laboratory tests to measure liver function, including alanine transaminase (ALT), aspartate aminotransferase (AST), and bilirubin levels, should be conducted at some point within 6 months of starting Aubagio and ALT levels should be checked monthly for the first six months you take Aubagio.

Pregnancy. Although there have been no well-controlled studies of Aubagio in women who are pregnant, results from studies conducted in animals indicate that Aubagio may cause harm to a fetus. Aubagio should not be taken if you are pregnant or planning to become pregnant. If you become pregnant while taking Aubagio, you should stop taking the drug immediately and contact your doctor.

Effects on bone marrow and potential for immunosuppression and infection. Aubagio can result in decreases in white blood cell counts and platelets. A complete blood cell count should be taken before starting Aubagio (within 6 months prior to starting treatment), and further monitoring should be done during treatment if there are signs that suggest bone marrow suppression. White blood cells are produced in the bone marrow.

There is increased risk of infection with Aubagio. If you have an infection (acute or chronic), you should not start Aubagio until the infection is resolved. If you develop a serious infection while taking Aubagio, you should consider discontinuing the drug and use an accelerated elimination procedure (as described by the manufacturer) to remove the drug from your system more quickly. Since Aubagio takes a long time to clear from the body, you may still experience the effects of the drug for a long time after discontinuing it. Aubagio is not recommended for use in people with severe immunodeficiency, bone marrow disease, or uncontrolled infections.

Effects in other organ systems. Aubagio can result in transient acute kidney failure, hyperkalemia (high levels of potassium in the blood), peripheral neuropathy, skin reactions, and respiratory effects. These effects may require monitoring (blood potassium, increases in blood pressure, and kidney function) and, in some cases, use of accelerated elimination to help clear Aubagio from the body.

 

Drug interactions

Aubagio should not be taken with the disease-modifying antirheumatic drug Arava (leflunomide).

Aubagio can increase your exposure to several drugs including the type II diabetes medications Prandin (repaglinide) and Actos (pioglitazone), Avandia (rosiglitazone), and the anticancer drug Taxol (paclitaxel). So, if you are taking Aubagio along with any of these drugs, you should be monitored.

If you are taking Aubagio and anticoagulant treatment with warfarin at the same time, you should be monitored closely. Aubagio can cause a 25% decrease in what is called the international normalized ratio (INR, a measure of blood clotting), which means that you may not be getting the amount of protection you need from warfarin and may need a dose adjustment.

Aubagio may interact with oral contraceptives. Therefore, you should talk to your doctor about an appropriate contraceptive method and dosage levels if you are taking Aubagio. When Aubagio was taken at the same time as ethinylestradiol and levonorgestrel, it caused increased exposure to these drugs.

If you take Aubagio and drugs including the serotonin-norepinephrine reuptake inhibitor Cymbalta (duloxetine), the anti-diarrhea medication Lotronex (alosetron), theophylline (used to treat chronic obstructive pulmonary disease (COPD) or asthma) and the muscle relaxant Zanaflex (tizanidine), you should be monitored. Aubagio can reduce your exposure to these drugs and decrease their effect.

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