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Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 26.06.2023
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Aubagio 14mg is the active metabolite of leflunomide, and it acts as an immunomodulatory agent by inhibiting pyrimidine synthesis. It is marketed under the name Aubagio 14mg® and is indicated for the treatment of multiple sclerosis, specifically relapsing forms. The FDA label states an important warning about the risk of hepatoxicity and teratogenicity for patients using Aubagio 14mg.
WHAT AUBAGIO IS AND WHAT IT IS USED FOR
AUBAGIO contains the active substance teriflunomide which is an immunomodulating agent that adjusts the immune system to limit its attack on the nervous system.
What AUBAGIO is used for
AUBAGIO is used in adults to treat relapsing remitting multiple sclerosis (MS).
What is multiple sclerosis
MS is a long-lasting disease that affects the central nervous system (CNS). The CNS consists of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective sheath (myelin) surrounding the CNS nerves. This loss of myelin is called demyelination. This causes the nerves to stop working properly.
People suffering from the recurrent form of multiple sclerosis will have repeated attacks (relapses) of physical symptoms caused by improper functioning of the nerves. These symptoms vary by patient, but typically include:
• difficulty walking
• vision problems
• balance problems.
Symptoms may disappear completely after relapse but, over time, some problems may remain. This can lead to physical disabilities that can interfere with your daily activities.
How AUBAGIO works
AUBAGIO helps protect against attacks on the central nervous system by the immune system, limiting the growth of some white cells (lymphocytes). This limits the inflammation that causes nerve damage in Ms.
HOW TO TAKE AUBAGIO
A doctor experienced in the treatment of multiple sclerosis will supervise the treatment with AUBAGIO.
Follow exactly the instructions for taking this medicine as directed by your doctor. If in doubt, check again to your doctor.
The recommended dose is one tablet of 14 mg daily.
Form / route of administration
AUBAGIO is administered orally. AUBAGIO is taken every day in a single daily dose at any time of the day.
The tablet should be swallowed whole with water.
AUBAGIO can be taken with or without food.
If you take more AUBAGIO than you should
If you have taken too much AUBAGIO, call your doctor immediately. You may experience side effects similar to those described in Section 4 (below).
If you forgot to take AUBAGIO
Do not take a double dose to make up for forgotten doses.
If you stop taking AUBAGIO
Do not stop treatment or change the dose of AUBAGIO without consulting your doctor first.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
See also:
What is the most important information I should know about Aubagio 14mg?
Aubagio 14mg is used to reduce flare-ups in people with relapsing multiple sclerosis (MS). Aubagio 14mg is not a cure for MS.
You should not use this medicine if you have severe liver disease, or if you are also taking leflunomide (Arava).
Aubagio 14mg can harm an unborn baby or cause birth defects. Do not use Aubagio 14mg if you are pregnant. Tell your doctor right away if you become pregnant during treatment or within 2 years after your treatment ends.
Use birth control to prevent pregnancy while you are using Aubagio 14mg, whether you are a man or a woman. Aubagio 14mg use by either parent may cause birth defects.
Aubagio 14mg can lower blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. While using Aubagio 14mg, you may need blood tests every 6 months. Your blood pressure will also need to be checked often.
After you stop taking Aubagio 14mg, the drug could stay in your body for up to 2 years. You may need to be treated with other medications to help your body eliminate Aubagio 14mg quickly. Follow your doctor's instructions.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone suffers from them.
The following side effects may occur with this medication.
Serious side effects
Tell your doctor immediately if you notice any of the following serious side effects:
- allergic reactions that could include symptoms of rash, wheezing, swelling of the lips, tongue, or face, or sudden difficulty breathing
- severe skin reactions that could include symptoms of rash, blisters, or ulcers in your mouth
- severe infections or sepsis (a type of infection that can be life-threatening) that could include symptoms such as high fever, tremors, chills, decreased urine flow, or confusion
- severe liver disease that could include symptoms such as yellowing of the skin or whites of the eyes, darker than normal urine, unexplained nausea and vomiting, or abdominal pain
- inflammation of the lungs that could include symptoms such as shortness of breath or persistent cough
- inflammation of the pancreas that could include symptoms such as severe pain in the upper abdominal area that could also be felt in your back, nausea or vomiting
Other side effects they can occur with the following frequencies:
Very common (may affect more than 1 in 10 people):
- Headache
- Diarrhoea, feeling sick
- Increased ALT (increase in certain liver enzymes in the blood) in the tests
- Hair thinning
FAQs (may affect up to 1 in 10 people):
- Influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and swallowing discomfort, cystitis, viral gastroenteritis, oral herpes, dental infection, laryngitis, foot fungal infection
- Laboratory values: a decrease in the number of red blood cells (anemia), changes in the liver and white blood cells have been observed in the analyzes (see Section 2), as well as elevations in muscle enzyme (creatinine phosphokinase)
- Mild allergic reactions
- Feeling anxious
- Aching, feeling weak, numbness, tingling or pain in the lower back or leg( sciatica), feeling numb, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome)
- Heart palpitation
- Increased blood pressure
- Feeling sick( vomiting), dental pain, pain in the upper abdominal region
- Rash, acne
- Pain in tendons, joints, bones, muscle pain (musculoskeletal pain)
- Need to urinate more often than normal
- Abundant periods
- Bread
- Weight loss
Uncommon (may affect up to 1 in 100 people):
- Decreased platelet count (mild thrombocytopenia)
- Increased sensitivity, especially in the skin, throbbing or pulsating pain in one or more nerves, problems with the nerves in the arms and legs (peripheral neuropathy)
- Post-traumatic pain
Frequency not known (frequency cannot be estimated with available data):
- Serious infections (including sepsis)
- Severe allergic reactions (including anaphylaxis)
- Pulmonary reaction (interstitial long disease, EPP)
- Inflammation of the liver, pancreas, or mouth / lips
- Severe skin reactions
- Nail disorders
- Lack of energy or feeling weak (asthenia)
- Abnormal level of fats (lipids) in the blood
Reporting of adverse effects
If you experience any side effects, talk to your doctor or pharmacist, even if these are any side effects not listed in this leaflet. You can also communicate them directly through the National Reporting System included in the Appendix V. By reporting side effects you can help provide more information about the safety of this medicine.
BEFORE YOU TAKE AUBAGIO
Do not take AUBAGIO:
- if you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in Section 6),
- if you have severe liver problems,
- if it is pregnant, you think you may be or are breast-feeding,
- if you have a serious problem affecting the immune system for example, acquired immunodeficiency syndrome (AIDS),
- if you have serious problems with your bone marrow or if you have a low number of leukocytes or red blood cells or a low number of platelets,
- if you have a serious infection,
- if you have serious kidney problems requiring dialysis,
- if you have too low a number of proteins in your blood (hypoproteinemia),
If in doubt ask your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking AUBAGIO if:
- if you have liver problems, your doctor may perform blood tests to check your liver function before and during treatment. If your test results indicate a problem with your liver, your doctor may stop taking AUBAGIO. See Section 4.
- you have high blood pressure (hypertension), whether or not you are being treated to control it. AUBAGIO can cause an increase in blood pressure. Your doctor will monitor your blood pressure before and regularly during treatment. See Section 4.
- he has an infection. Before you start taking AUBAGIO, your doctor will make sure you have enough leukocytes and platelets in your blood. Since AUBAGIO decreases the number of leukocytes in the blood, this can affect your ability to fight infection. Your doctor may do blood tests to check your white blood cells if you think you have an infection. See Section 4.
- it has severe skin reactions.
- he has respiratory symptoms.
- he has weakness, numbness and pain in his hands and feet.
- he's going to get vaccinated.
- take leflunomide with AUBAGIO.
- they're changing your medication from or to AUGABIO.
- it is lactose intolerant.
- you are scheduled to have a specific blood test (calcium level). A false decrease in calcium levels may be detected.
Children and adolescents
AUBAGIO should not be used in children and adolescents under 18 years of age. This is because the effects of this drug in this age group are unknown.
Other medicines and AUBAGIO
Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicines. This includes over-the-counter medications.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- leflunomide, methotrexate and other medicines that affect the immune system (often called immunosuppressants or immunomodulators)
- rifampicin (a medicine used to treat tuberculosis and other infections)
- carbamazepine, phenobarbital, phenytoin for epilepsy
- hypericum (a herbal medicine for depression)
- repaglinide, pioglitazone, nateglinide or rosiglitazone for diabetes
- daunorubicin, doxorubicin, paclitaxel or topotecan for cancer
- Duloxetine for depression, urinary incontinence or in kidney disease in diabetics
- allosetron for severe cases of diarrhea
- theophylline for asthma
- Tizanidine, a muscle relaxant
- warfarin, an anticoagulant to thin the blood (make it more fluid) and prevent clots
- oral contraceptives (ethinyl estradiol, levonorgestrel)
- cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
- indomethacin, ketoprofen for pain or inflammation
- furosemide for heart disease
- cimetidine to reduce gastric acid
- zidovudine for AIDS
- rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol).
- sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
- Cholestyramine for high cholesterol or relief of itching in liver disease.
- activated carbon to reduce the absorption of drugs or other substances.
Pregnancy and lactation
No take AUBAGIO if you are pregnant or think you may be pregnant. If you are pregnant or become pregnant while taking AUBAGIO, your risk of having a baby with birth defects will increase. Women of childbearing potential should not take this medicine if they are not using reliable birth control methods.
Tell your doctor if you plan to become pregnant after stopping treatment with AUBAGIO, as you need to make sure that most of this medicine has been removed from your body before attempting to become pregnant. The removal of the active substance in a natural way can take up to 2 years. This time period can be reduced to a few weeks by taking certain medications to speed up the removal of AUBAGIO from the body.
In any case, you need your doctor to confirm, from a blood test, that the level of active substance in the blood is low enough to be able to become pregnant.
For more information about laboratory tests, contact your doctor.
If you suspect that you are pregnant while taking AUBAGIO or within two years of ending treatment, you should contact your doctor immediately to perform a pregnancy test. If the test confirms pregnancy, your doctor may suggest treatment with certain medications to remove AUBAGIO from your body quickly and sufficiently, as this may decrease the risk to your baby.
Contraception
You must use effective contraception during and after treatment with AUBAGIO. Teriflunomide remains in your blood for a long time after you stop taking it. Continue to take contraceptive measures after stopping treatment.
• Keep doing this until your blood levels of AUBAGIO are low enough (your doctor will check).
• Consult your doctor about the best method of birth control for you and in case you need to Change Method.
Do not take AUBAGIO during breast-feeding as teriflunomide passes into breast milk.
Driving and using machines
AUBAGIO can cause dizziness, which can affect the ability to concentrate and react. If affected, do not drive or use machines.
AUBAGIO contains lactose
AUBAGIO contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, check with him before taking this medicine.
See also:
What are the possible side effects of Aubagio 14mg?
The following serious adverse reactions are described elsewhere in the prescribing information:
- Hepatotoxicity
- Bone Marrow Effects /Immunosuppression Potential/Infections
- Hypersensitivity and Serious Skin Reactions
- Peripheral Neuropathy
- Increased Blood Pressure
- Respiratory Effects
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 14mg (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 14mg 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 14mg 7 mg, Aubagio 14mg 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 14mg 7 mg (N=1045) | Aubagio 14mg 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 14mg in the premarketing database. These cardiovascular deaths occurred during uncontrolled extension studies, one to nine years after initiation of treatment. A relationship between Aubagio 14mg 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 14mg group and 6/1002 (0.6%) patients in the 14 mg Aubagio 14mg group versus 4/997 (0.4%) patients in the placebo group. These elevations were transient. Some elevations were accompanied by hyperkalemia. Aubagio 14mg may cause acute uric acid nephropathy with transient acute renal failure because Aubagio 14mg increases renal uric acid clearance.
Hypophosphatemia
In clinical trials, 18% of Aubagio 14mg-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 14mg-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.
Post-Marketing Experience
The following adverse reactions have been identified during post approval use of Aubagio 14mg. 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.
- Hypersensitivity reactions, some of which were severe, such as anaphylaxis and angioedema
- Severe skin reactions, including toxic epidermal necrolysis and Stevens-Johnson syndrome
- Thrombocytopenia
- Interstitial lung disease
- Pancreatitis