Tofacitinib

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  • For more information, please download leaflet.

    • The brand name of your medication is Rhofanib® and the generic name is Tofacitinib.
    • Rhofanib® is a medicine used to treatment of rheumatoid arthritis and rheumatoid arthritis by controlling the immune system.
    • This medication is a film-coated tablet in dosage of 5 mg. each box contains 56 film coated tablet (four blister and each blister contains 14 film coated tablets).

    1 Why is Rhofanib® prescribed?

    It is used to treat moderate to severe rheumatoid arthritis in adult patients whose symptoms have not better with methotrexate therapy. RHOFANIB® may be prescribed concomitantly with methotrexate or other medications for treatment of Rheumatoid arthritis. Another use of this drug in the treatment of psoriatic arthritis, which has no adequate response to methotrexate or other treatments for this disease.

    RHOFANIB® may be prescribed in other conditions which had not been mentioned here

    2 How Rhofanib® should be taken?

    • Take Rhofanib® according to your doctor’s order. Your doctor will talk to you about amount and interval of using tablets.
    • Rhofanib® is usually given twice a day, each time one tablet alone or in combination with methotrexate or other medicines to treat rheumatoid arthritis.
    • Before start taking Rhofanib®, your doctor will ensure that you do not have tuberculosis and other infections.
    • Rhofanib® can be taken in each time without regarding to meal time.
    • Avoid taking excessive amounts of medication or less than prescribed or more than the prescribed time for consumption and just change your medication with your doctor's command.
    • If you have any more question about Rhofanib® talk to your doctor, pharmacist or other health care providers.

    3 What special precautions should you follow during your treatment with Rhofanib®?

    • Before and during treatment, hepatitis B tests may be prescribed by your doctor, because taking this medicine may increase the severity of hepatitis if you have this infection.
    • Your doctor will prescribe some tests to ensure that you do not have tuberculosis before and during treatment.
    • Before taking any medical and surgical intervention, inform your doctor or dentist about taking Rhofanib®.
    • There have been reports of severe infections associated with the use of this drug. If you have any type of infection, you are currently taking or have recently taken antibiotics or if you have been infected or have symptoms of an infection, you should inform your doctor.
    • Before you receive any vaccine, be sure to consult your physician because you are at risk of infection or the vaccine may not be necessary for you. Also, avoid close contact with people who have received a live vaccine recently.
    • Be sure to do all the recommended tests from your doctor and inform him about results.
    • Be sure to inform your doctor if you are breast-feeding, have a pregnancy, suspect that you are pregnant, such as menstrual periods, abnormal bleeding, and discontinuation of contraception and intent to become pregnant.

    4 What are some side effects that you need to call your doctor about right away?

    • In case of any signs of allergy including: skin irritation, hives, itching, redness, peeling skin with or without fever, swelling of the mouth, face, lips, tongue or throat, wheezing, chest tightness and throat, difficulty in breathing, talking or unusual sound;
    • in case of any symptoms of infection include fever of 38 ° C or higher, chills, severe burning of the throat, ear or pain in the sinus region, coughing, increased or altered sputum color, pain and burning sensation when urinating, Oral ulcers, wounds that do not heal, itching or pain in the anus;
    • Sudden onset of skin rash or spot;
    • Severe breathing difficulties, persistent cough, cough with blood, abnormal weight loss;
    • any kind of bruising or bleeding;
    • In case of severe headaches, neck stiffness and severe light sensation;
    • Fatigue and severe weakness, pain in the body, itching and fever;
    • Severe abdominal pain;
    • No ability to eat and lose appetite;
    • Stool with bright color, darkness of the urine or yellowish of the skin or eyes;
    • Contact your doctor immediately if you notice any symptoms that do not improve or get worse over time.

    5 What is the storage condition of Rhofanib®?

    Keep Rhofanib® in main Box and away from light and moisture and below 30°C.

    Keep medicine out of the reach of children.

  • For more information, please download leaflet.

    • RHOFANIB® (TOFACITINIB) tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor.
    • RHOFANIB® is supplied for oral administration as 5 mg tofacitinib (equivalent to 8 mg tofacitinib citrate) white round, immediate-release film-coated tablet.
    • Each tablet of RHOFANIB® contains the appropriate amount of tofacitinib as a citrate salt.

    1 INDICATIONS AND USAGE

    1.1. Rheumatoid Arthritis

    TOFACITINIB is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to Methotrexate. It may be used as monotherapy or in combination with Methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

    Limitations of Use: TOFACITINIB in combination with biologic DMARDs or with potent immune suppressants such as Azathioprine and Cyclosporine is not recommended.

    TOFACITINIB is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other Disease-Modifying Antirheumatic Drugs (DMARDs).

    Limitations of Use: Use of TOFACITINIB in combination with biologic DMARDs or with potent immune suppressants such as Azathioprine and Cyclosporine is not recommended.

    2 DOSAGE AND ADMINISTRATION

    2.1. Dosage in Rheumatoid Arthritis

    TOFACITINIB may be used as monotherapy or in combination with methotrexate or other nonbiologic Disease-Modifying Antirheumatic Drugs (DMARDs). The recommended dose of TOFACITINIB is 5 mg twice daily.

    TOFACITINIB is given orally with or without food.

    2.2. Dosage in Psoriatic Arthritis

    The recommended dose of TOFACITINIB is 5 mg twice daily, used in combination with nonbiologic DMARDs.

    2.3. Dosage Modifications due to Serious Infections and Cytopenias

    It is recommended that TOFACITINIB not be initiated in patients with an absolute lymphocyte count less than 500 cells/mm3, an absolute neutrophil count (ANC) less than 1000 cells/mm3 or who have hemoglobin levels less than 9 g/dL.

    Dose interruption is recommended for management of lymphopenia, neutropenia and anemia. Avoid use of TOFACITINIB if a patient develops a serious infection until the infection is controlled.

    2.4. Dosage Modifications due to Drug Interactions

    In patients receiving:

    potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., Ketoconazole), or one or more concomitant medications that result in both moderate inhibitions of CYP3A4 and potent inhibition of CYP2C19 (e.g., Fluconazole), the recommended dose is TOFACITINIB 5 mg once daily.

    Co-administration of potent inducers of CYP3A4 (e.g., Rifampin) with TOFACITINIB may result in loss of or reduced clinical response to TOFACITINIB.

    Co-administration of potent inducers of CYP3A4 with TOFACITINIB is not recommended.

    2.5. Dosage Modifications in Patients with Renal or Hepatic Impairment

    In patients with:

    moderate or severe renal insufficiency, or

    moderate hepatic impairment, the recommended dose is TOFACITINIB 5 mg once daily. Use of TOFACITINIB in patients with severe hepatic impairment is not recommended

    3 CONTRAINDICATIONS:

    No known contraindications.

    4 USE IN SPECIAL POPULATIONS

      4.1. Pregnancy

      Pregnancy Risk Factor: C

      Pregnancy Implications: There are no adequate and well-controlled studies in pregnant women. TOFACITINIB should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. tofacitinib has been shown to be fetocidal and teratogenic in rats and rabbits when given at exposures 146 times and 13 times, respectively, the maximum recommended human dose (MRHD).

      4.2. NURSING MOTHERS:

      Excretion in breast milk unknown/not recommended.

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