Ehlafra Dosage

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Dosage of Ehlafra in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Ehlafra Dosage

Generic name: Ehlafra 10mg

Dosage form: tablet, film coated

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Recommended Dosage

The recommended dosage of Ehlafra is 20 mg once daily. Treatment may be initiated with or without a loading dose, depending upon the patient's risk of Ehlafra-associated hepatotoxicity and Ehlafra-associated myelosuppression. The loading dosage provides steady-state concentrations more rapidly.

  • For patients who are at low risk for Ehlafra-associated hepatotoxicity and Ehlafra-associated myelosuppression the recommended Ehlafra loading dosage is 100 mg once daily for 3 days. Subsequently administer 20 mg once daily.
  • For patients at high risk for Ehlafra-associated hepatotoxicity (e.g., those taking concomitant methotrexate) or Ehlafra-associated myelosuppression (e.g., patients taking concomitant immunosuppressants), the recommended Ehlafra dosage is 20 mg once daily without a loading dose.

The maximum recommended daily dosage is 20 mg once per day. Consider dosage reduction to 10 mg once daily for patients who are not able to tolerate 20 mg daily (i.e., for patients who experience any adverse events listed in Table 1).

Monitor patients carefully after dosage reduction and after stopping therapy with Ehlafra, since the active metabolite of Ehlafra, teriflunomide, is slowly eliminated from the plasma. After stopping Ehlafra treatment, an accelerated drug elimination procedure is recommended to reduce the plasma concentrations of the active metabolite, teriflunomide. Without use of an accelerated drug elimination procedure, it may take up to 2 years to reach undetectable plasma teriflunomide concentrations after stopping Ehlafra.

Evaluation and Testing Prior to Starting Ehlafra

Prior to starting Ehlafra treatment the following evaluations and tests are recommended:

  • Evaluate patients for active tuberculosis and screen patients for latent tuberculosis infection
  • Laboratory tests including serum alanine aminotransferase (ALT); and white blood cell, hemoglobin or hematocrit, and platelet counts
  • For females of reproductive potential, pregnancy testing
  • Check blood pressure

More about Ehlafra (Ehlafra)

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  • During Pregnancy
  • Dosage Information
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  • Drug Interactions
  • Support Group
  • Pricing & Coupons
  • En Espanol
  • 19 Reviews - Add your own review/rating
  • Generic Availability

Consumer resources

  • Ehlafra
  • Ehlafra (Advanced Reading)

Professional resources

  • Ehlafra (AHFS Monograph)
  • Ehlafra (FDA)

Related treatment guides

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What other drugs will affect Ehlafra?

Before taking Ehlafra, tell your doctor if you are taking cholestyramine (Questran, Prevalite, LoCHOLEST) or rifampin (Rifadin, Rimactane).

Also tell your doctor if you are using medications that can weaken your immune system, such as:

  • methotrexate (Rheumatrex, Trexall);
  • cancer medications;
  • cyclosporine (Neoral, Sandimmune, Gengraf);
  • sirolimus (Rapamune), tacrolimus (Prograf);
  • basiliximab (Simulect), muromonab-CD3 (Orthoclone);
  • mycophenolate mofetil (CellCept); or
  • azathioprine (Imuran), etanercept (Enbrel).

Ehlafra can harm your liver. This effect is increased when you also use other medicines harmful to the liver, such as:

  • acetaminophen (Tylenol);
  • tuberculosis medications;
  • birth control pills or hormone replacement therapy;
  • other arthritis medications such as auranofin (Ridaura) or aurothioglucose (Solganol);
  • an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others;
  • an antibiotic such as dapsone or erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole);
  • an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral);
  • cholesterol medications such as niacin (Advicor, Niaspan, Niacor, Slo-Niacin, and others), atorvastatin (Lipitor, Caduet), simvastatin (Zocor, Simcor, Vytorin), and others;
  • HIV/AIDS medications such as abacavir/lamivudine/zidovudine (Trizivir), lamivudine (Combivir, Epivir), nevirapine (Viramune), tenofovir (Viread), or zidovudine (Retrovir);
  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or
  • seizure medications such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), felbamate (Felbatol), valproic acid (Depakene).

This list is not complete and other drugs may interact with Ehlafra. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Ehlafra interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Ehlafra, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Following oral administration, Ehlafra is metabolized to an active metabolite, teriflunomide, which is responsible for essentially all of Ehlafra's in vivo activity. Drug interaction studies have been conducted with both Ehlafra (Ehlafra) and with its active metabolite, teriflunomide, where the metabolite was directly administered to the test subjects.

Effect of Potent CYP and Transporter Inducers

Ehlafra is metabolized by CYP450 metabolizing enzymes. Concomitant use of Ehlafra and rifampin, a potent inducer of CYP and transporters, increased the plasma concentration of teriflunomide by 40%. However, when co-administered with the metabolite, teriflunomide, rifampin did not affect its pharmacokinetics. No dosage adjustment is recommended for Ehlafra when coadministered with rifampin. Because of the potential for Ehlafra concentrations to continue to increase with multiple dosing, caution should be used if patients are to be receiving both Ehlafra and rifampin.

Effect on CYP2C8 Substrates

Teriflunomide is an inhibitor of CYP2C8 in vivo. In patients taking Ehlafra, 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 on Warfarin

Coadministration of Ehlafra with warfarin requires close monitoring of the international normalized ratio (INR) because teriflunomide, the active metabolite of Ehlafra, may decrease peak INR by approximately 25%.

Effect on oral Contraceptives

Teriflunomide may increase the systemic exposures of ethinylestradiol and levonorgestrel. Consideration should be given to the type or dose of contraceptives used in combination with Ehlafra.

Effect on CYP1A2 Substrates

Teriflunomide, the active metabolite of Ehlafra, may be a weak inducer of CYP1A2 in vivo. In patients taking Ehlafra, 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 on Organic Anion Transporter 3 (OAT3) Substrates

Teriflunomide inhibits the activity of OAT3 in vivo. In patients taking Ehlafra, 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 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 Ehlafra, 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 Ehlafra.


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References

  1. DailyMed. "LEFLUNOMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. FDA/SPL Indexing Data. "G162GK9U4W: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
  3. MeSH. "Immunosuppressive Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Ehlafra are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Ehlafra. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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