What is Ehlafra?

Ehlafra affects the immune system and reduces swelling and inflammation
Ehlafra affects the immune system and reduces swelling and inflammation

Ehlafra affects the immune system and reduces swelling and inflammation in the body. Ehlafra is used to treat the symptoms of rheumatoid arthritis. Ehlafra also helps reduce joint damage and improves physical functioning.

Ehlafra may also be used for other purposes not listed in this medication guide.

EHLAFRA INDICATIONS

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pain

Treatment of active rheumatoid arthritis (RA) in adults to reduce signs and symptoms, inhibit structural damage as evidence by X-ray erosions and joint space narrowing, and improve physical function.

Aspirin, nonsteroidal anti-inflammatory agents and/or low dose corticosteroids may be continued during treatment with Ehlafra. The combined use of Ehlafra with antimalarials, IM or oral gold, D-penicillamine, azathioprine or methotrexate has not been adequately studied.

HOW SHOULD I USE EHLAFRA?

Use Ehlafra as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Ehlafra by mouth with or without food.
  • It may take 4 weeks or more to notice any improvement while taking Ehlafra.
  • If you miss a dose of Ehlafra, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ehlafra.

USES OF EHLAFRA IN DETAILS

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it.

Use: Labeled Indications

Rheumatoid arthritis: Treatment of adults with active rheumatoid arthritis (RA).

Off Label Uses

BK virus (viremia or nephropathy; in kidney transplant recipients)

Data from a small retrospective study suggest Ehlafra may be of benefit as a replacement for mycophenolate in kidney transplant recipients with BK virus (viremia or nephropathy).

EHLAFRA DESCRIPTION

Ehlafra is a pyrimidine synthesis inhibitor belonging to the DMARD (disease-modifying antirheumatic drug) class of drugs, which are chemically and pharmacologically very heterogeneous. Ehlafra was approved by FDA and in many other countries (e.g., Canada, Europe) in 1999.

EHLAFRA DOSAGE

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

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