Aubagio ( Teriflunomide ) has been shown to reduce the frequency of exacerbations in ambulatory patients with relapsing remitting multiple sclerosis, this effect seems similar to that of the interferon β preparations and glatiramer.
There is no evidence for an effect on the reduction of exacerbations in the primary or secondary progressive disease. Little is known about the long-term effects in MS.
As with interferon β, the start and stop criteria are not clear. A favorable effect on the progress of disability has not been sufficiently demonstrated. An advantage of Aubagio over interferon β and glatiramer is the oral administration; a disadvantage is the lesser experience.
Aubagio ( Teriflunomide ) tablets have been on the international market since 2012. It suppresses body defenses and inhibits inflammation. Aubagio is used to treat adults with relapsing remitting multiple sclerosis (MS). It should be noted that Aubagio does not treat the MS. In multiple sclerosis (MS) disease, body defenses attack their own nerve cells, causing them to become inflamed.
It may take several months before you notice the effect of Aubagio ( Teriflunomide ) and the symptoms to decrease. If this medicine works for you, you can continue to use it for a number of years.
What’s Multiple Sclerosis?
MS is a chronic disease of the central nervous system (CNS), which includes the brain and spinal cord. Multiple sclerosis causes inflammatory processes that destroy the protective lining (also called the myelin sheath) of the nerves of the CNS and thus hinder their proper functioning. This process is called demyelination.
Relapsing remitting MS is characterized by the recurrence of neurological symptoms (bouts) caused by inflammation in the CNS. The symptoms vary from patient to patient, but most of them are difficulty walking, numbness, and vision and balance disorders. The symptoms of a push can completely recede once it is over. However, some inter-episode discomfort may persist and result in physical limitations that may interfere with daily life.
The complaints of MS depend on the nerves that are affected. Often MS starts with fatigue and less vision with one eye. Sometimes there are also muscle spasms and feeling disorders, such as tingling. The complaints can occur in attacks (schubs), but can also be present continuously.
MS is treated by a neurologist. Thereby the neurologist tries to prevent new schubs and ensure that you can continue to do your daily activities.
The inflammation treats the neurologist with immune suppressors, such as an adrenal cortex hormone. This should prevent new schubs. If an adrenal hormone does not help sufficiently, the doctor may prescribe another immunosuppressant such as teriflunomide.
– Active substance: Teriflunomide. Each tablet contains 14 mg teriflunomide.
– Other ingredients: Lactose monohydrate, corn starch, microcrystalline cellulose, sodium starch glycolate (type A), hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide (E171), talc, macrogol, indigo carmine (E132).
Aubagio 14 mg are light to pastel blue, pentagonal film-coated tablets; On one side is printed the number “14” (dosage), on the other the logo of the laboratory is imprinted.
How to Use Aubagio ?
Treatment with Aubagio should be initiated under the supervision of a physician experienced in the treatment of multiple sclerosis. When taking Aubagio, always follow the dosing instructions of your doctor. If in doubt, consult your doctor.
You may take the medicine at any time of the day. It is best to choose a fixed time, for example in the morning. Then you forget a dose less quickly.
The usual dose consists of one tablet per day. The tablet must be swallowed without being crushed. Take in with half a glass of water. Do you suffer from nausea? Take it in during meals or with some food.
The following side effects may occur when taking Aubagio:
The most common side effects include:
- A headache,
- Diarrhea, nausea,
- Increase in ALT levels (increase in the concentration of certain liver enzymes in the blood),
- Hair loss.
Among the common side effects include:
- Influenza syndrome, upper respiratory tract infection, urinary tract infections, bronchitis, sinusitis, sore throat and dysphagia; cystitis; viral gastroenteritis; Cold sores; Dentogenic infection; Laryngitis; Athlete’s foot,
- Hay fever,
- Sciatica syndrome; carpal tunnel syndrome,
- Increase in blood pressure,
- Stomach pain, vomiting, toothache,
- Redness, acne,
- musculoskeletal pain, muscle pain,
- frequent urination,
- heavy menstrual bleeding,
- Blood levels indicative of changes in liver function or reduction in white blood cell count, reduction in red blood cell counts or a slight reduction in the number of platelets, as well as increase in a muscle enzyme (creatine phosphokinase).
- Weight loss.
There have been occasional reports of sensory disturbances or increased sensitivity, particularly to the skin, pulsating or stabbing pain along one or more nerve tracts, and post-traumatic pain.
You are also more likely to have infections. Report it to your doctor if you have sore throat or flu or if you get a cold sore, shingles or a fungal infection.
Cases of allergic reactions, severe skin reactions, mouth ulcers, inflammation of the pancreas (pancreatitis) and severe infections including sepsis have also been reported in Aubagio-treated patients.
In addition, cases of sudden cardiac death and myocardial infarction have been reported in Aubagio-treated patients.
If you experience any of these side effects or notice any side effects not listed here, you should tell your doctor or pharmacist.
In the event of a fever (more than 38 degrees Celsius), always contact your doctor.
Aubagio may not be used in the following cases:
- if you are allergic to teriflunomide or any other ingredient of Aubagio.
- if you are already being treated with the related active substance leflunomide.
- if you have severe hepatic insufficiency.
- if you have severe dialysis kidney failure.
- if you have a serious immune deficiency (for example, AIDS).
- if you have bone marrow insufficiency or a significantly reduced number of blood cells (red blood cells, white blood cells or platelets).
- if you have a serious infection.
- if you are pregnant or of childbearing age and you are not using a reliable contraceptive method, or if you are breastfeeding.
- if you are young (under 18 years) or older (over 65 years).
- if you have a severe protein deficiency in the blood, as it occurs in the context of the kidney disease nephrotic syndrome .
Only after careful consideration of the benefit and risk by the physician and under his control may teriflunomide be used in
- Patients with pre-existing liver disease because these can quickly derail liver function
- Patients who drink significant amounts of alcohol because it also causes liver damage
- High blood pressure, because this can increase even more through the treatment
- Changes in the blood picture, because these can increase.
Ask your doctor or pharmacist or your doctor for advice before taking Aubagio:
- if you have liver disease
- if you have high blood pressure (arterial hypertension), whether or not it is being treated with medication;
- if you are planning a vaccination;
- if you have diabetes, lung disease or infections.
Liver test: The use of Aubagio may cause abnormal results in liver function tests. If you notice yellowing of the skin or the eyes, a noticeable darkening of the urine, unexplained nausea and vomiting, abdominal pain or tiredness, you must tell your doctor immediately. During treatment, your doctor will regularly perform blood tests to monitor your liver function. If any hepatic impairment is found in these studies, you may need to stop taking Aubagio.
In addition, alcohol consumption in significant amounts during treatment is discouraged.
High blood pressure: Since Aubagio causes a slight increase in blood pressure, your doctor will perform regular blood pressure checks.
Infections: you are more susceptible to infections while being treated with Aubagio. If you already have an infection, it could get worse. These infections can be serious or even life-threatening. If you suspect that you have an infection, fever or a flu infection, you should contact your doctor immediately.
Blood count: Aubagio lowers the number of white blood cells. If you get a blood count, you should tell your doctor that you are taking Aubagio. Otherwise, he / she may misinterpret the results of the blood test.
Before starting treatment with Aubagio, your doctor will check if there are enough white blood cells in your blood. These checks can then be carried out regularly.
Malignancy: The cancer risk is increased with the use of certain immunomodulatory agents, however, in clinical trials with Aubagio, there was no increase in the frequency of malignant tumors or lymphoproliferative disorders associated with the treatment.
Peripheral neuropathy: If symptoms of peripheral neuropathy occur during treatment, discontinuation of treatment and washout should be considered.
Acute renal impairment: Aubagio may increase uric acid excretion, resulting in uretal nephropathy, which can cause lumbar pain. Concomitant treatment with drugs that reduce uric acid like Probenzide or Losartan should be done with caution.
Hyperkalemia: Your potassium level must be controlled when you are being treated with Aubagio and have symptoms of hyperkalaemia (tremor, touch, heart failure) or acute renal insufficiency (anuria, fatigue, edema).
Severe skin reactions: If serious skin lesions occur during treatment with Aubagio, the therapy must be stopped and washout procedures initiated.
Respiratory reactions: Pulmonary complaints such as coughing or shortness of breath, or an exacerbation of these symptoms, with or without fever, may require discontinuation of treatment and, possibly, elimination measures.
It takes several weeks before teriflunomide is completely released from your body. Therefore, in the case of serious adverse effects even after discontinuation of therapy washout measures should be taken.
Aubagio contains lactose monohydrate, a type of sugar. If you are intolerant of certain sugars, talk to your doctor before taking this medicine.
Use while Driving
Your doctor will decide if your illness will allow you to operate a vehicle and machinery without jeopardizing your safety. Aubagio has no influence on the ability to drive and use machines.
Talk to your doctor or pharmacist if you are taking or have recently taken any other prescription or nonprescription medicine. Teriflunomide itself influences the effects of other drugs. It is especially important that you tell your doctor if you are taking any of the following medicines:
- Medicines that affect the immune system (often referred to as immunosuppressants or immunomodulators);
- Rifampicin, which is indicated for the treatment of tuberculosis as rifampicin accelerates the degradation of teriflunomide so much that its blood concentration is reduced by 40% and the effect is thus greatly attenuated.
- Carbamazepine, phenobarbital, phenytoin (antiepileptic drugs);
- St. John’s wort, a plant for the treatment of depression;
- Repeated doses of teriflunomide in the antidiabetic agents nateglinide , repaglinide , pioglitazone and rosiglitazone cause an increase in blood concentration, which can lead to low blood sugar levels.
- Paclitaxel, methotrexate, topotecan, daunorubicin or doxorubicin used in the treatment of cancer;
- Duloxetine for the treatment of depression;
- Alosetron, which is used to treat severe diarrhea;
- Theophylline for the treatment of asthma;
- Tizanidine, a muscle relaxant;
- Warfarin or phenprocoumon, anticoagulant drugs that liquefy the blood to prevent the blood clots; the doctor will carefully monitor the blood clotting in combination.
- Cefaclor, penicillin G, ciprofloxacin and other antibiotics in case of long-term treatment;
- Indomethacin, ketoprofen, sulfasalazine (anti-inflammatory drugs);
- Rosuvastatin, simvastatin, atorvastatin, pravastatin (lipid-lowering);
- Zidovudine (medicines for the treatment of AIDS);
- Cimetidine (medicine for the treatment of gastric ulcers);
- Furosemide (diuretic);
- Oral contraceptives; The blood concentration of ethinylestradiol + levonorgestrel , components of the pill, may also increase. Therefore, the doctor may change the contraceptive during treatment with teriflunomide.
- Cyclosporine; Eltrombopag and gefitinib.
- Activated carbon, but also the blood lipid cholestyramine bind teriflunomide and quickly expel it from the body. The effect of teriflunomide decreases rapidly, so patients receiving the drug should not be treated with these substances.
Pregnancy & Lactation
Do not use if you are pregnant. Use good contraception when you start this medication, up to 2 years after stopping.
Women should avoid getting pregnant while taking Aubagio. Aubagio stays in the blood for a long time after stopping the treatment. For this reason, you should prevent it until the concentration of Aubagio in your blood has dropped sufficiently. Talk to your doctor about reliable contraceptive methods you should use during treatment.
If you think you may be pregnant, or want to become pregnant during the treatment, or within two years after the end of treatment, and have not taken any medication to completely remove Aubagio from your blood, contact your doctor immediately You are being tested for pregnancy. If the test is positive, your doctor will prescribe a course of medication that will help Aubagio get out of the body faster, reduce the risk of harm to your unborn child and discuss how to proceed.
During breast-feeding you must not take Aubagio. Teriflunomide can pass into breast milk.
The cholestyramine absorbent (Questran) or activated carbon (Norit powder) removes teriflunomide from the body more quickly. These drugs bind to teriflunomide and dissipate it faster.
Usually, you must use these absorbents for at least 11 days to ensure that the amount of teriflunomide in the body has dropped sufficiently. Your doctor can check this by regularly measuring the amount in the blood.
Questions & Answers
Can I take Aubagio with food and drink ?
Aubagio can be taken during or outside meals.
Is Aubagio suitable for children and adolescents ?
Aubagio is not indicated for use in children and adolescents as the safety and efficacy of teriflunomide in children aged 10 to 18 years has not yet been established. This is mainly because the disease usually breaks out later. Thus, no studies with the mentioned age group were carried out.
What to do If you take more Aubagio than prescribed ?
If you take Aubagio in quantities greater than prescribed, please consult your doctor immediately.
What to do if you missed a dose ?
If you miss a dose, take the next dose as scheduled. Do not take a double dose to compensate.
Can I stop the treatment with Aubagio at anytime ?
Do not interrupt the treatment with Aubagio and do not change the prescribed dosage without first consulting your doctor. Do not change the prescribed dose on your own. Consult your doctor, pharmacist or pharmacist if you think the medication is too weak or too strong.
Store Aubagio out of reach of children. It must be stored at room temperature (15-25 ° C) and must only be used up to the date marked on the container with “EXP”.
Where to Buy ?
In pharmacies, on medical prescription. The estimated price is 1890,83 EUR in Europe and $4,757.19 for every 30 tablets in the united states
Sanofi Aventis and Genzyme that’s a Sanofi company.
Aubagio is available in carton packs of 28 or 84 tablets in aluminum blister and cardboard box.