Tofacit 5 Tablet 1 Strip

✔️ Dosage & Administration of Tofacit 5 (Tofacitinib)

Adult Dose (Rheumatoid Arthritis)

Tofacit 5 is indicated as a second-line therapy for adults with moderate to severe active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Recommended Dose:
5 mg taken twice daily.

Use Options:
Can be administered as monotherapy or in combination with methotrexate or other non-biologic DMARDs.

Hepatic Impairment

Mild Impairment:
No dose adjustment required.

Moderate Impairment:
Maximum dose should not exceed 5 mg once daily.

Severe Impairment:
Not recommended for use.

Renal Impairment

Mild Renal Dysfunction:
No dose adjustment required.

Moderate to Severe Renal Dysfunction:
Do not exceed 5 mg once daily.

Pediatric Use

Children:
The safety and efficacy of Tofacit 5 in individuals under 18 years of age have not been established.

1. The dose should be taken as prescribed by the physician, typically twice daily.
2. It may take 3 to 6 months to achieve full therapeutic benefit.
3. Continue the treatment as directed, even if the effects are not immediate.

✔️ Regular laboratory tests may be recommended to monitor:

• Liver function
• Kidney function
• Blood counts (CBC)
• Lipid profile (cholesterol levels)
• Signs of infection or immunosuppression
• A tuberculosis (TB) skin test and chest X-ray may be required before initiating treatment to rule out latent TB.

✔️ Drug Interactions

Increased Drug Levels:
Caution is advised when used with:

Potent CYP3A4 inhibitors (e.g., ketoconazole)

Moderate CYP3A4 inhibitors and potent CYP2C19 inhibitors (e.g., fluconazole)
These agents may increase the plasma concentration of tofacitinib.

Decreased Drug Levels:
Concomitant use with strong CYP enzyme inducers (e.g., rifampin) can reduce the effectiveness of tofacitinib by lowering its blood levels.

Other Interactions:

Co-administration with tacrolimus or cyclosporine may result in increased AUC and decreased Cmax of tofacitinib.

Tofacitinib may lower both the AUC and Cmax of methotrexate (MTX) when used together.

✔️ Pregnancy & Contraception Guidance

Pregnancy Use

Pregnancy Registry:
A dedicated registry tracks pregnancy outcomes in women exposed to tofacitinib during pregnancy. Patients may report by calling 1-877-311-8972.

Human Data:
There are currently no adequate or well-controlled studies on the use of tofacitinib in pregnant women. Cases of birth defects and miscarriage have been reported during clinical trials.

Animal Studies:
Findings from animal research suggest that tofacitinib may harm a developing fetus and may reduce fertility in females. In rats, exposure was associated with adverse effects on embryo development and female reproductive function.

Contraception Advice

Women of reproductive age should be advised to use effective birth control during treatment and for at least 4 weeks after the last dose of tofacitinib.

✔️ Side Effects of Tofacit 5 (Tofacitinib)

Common Side Effects

• Headache
• Diarrhea
• Increased cholesterol levels
• High blood pressure
• Nausea
• Upper respiratory tract infections

Serious Side Effects

• Severe infections (e.g., TB, pneumonia)
• Blood clots
• Liver dysfunction
• Low blood counts (anemia, neutropenia)
• Gastrointestinal perforation (rare)

✔️ Precautions for Use of Tofacit 5 (Tofacitinib)

1. Risk of Serious Infections

• Do not initiate tofacitinib in patients with active infections, including localized, chronic, or recurrent infections.
• If a serious infection occurs during treatment, discontinue the medication until the infection is fully resolved.
• Patients should be monitored closely for signs of infection such as fever, cough, or fatigue, especially those with a history of infections or those using immunosuppressive therapies.

2. Malignancy Risk

• Cases of lymphoma and other cancers have been reported in patients treated with tofacitinib.
• Use caution in patients with a history of malignancies or who are at increased cancer risk.

3. Gastrointestinal Perforation

• Use cautiously in patients at increased risk of gastrointestinal (GI) perforations, such as those with diverticulitis or on NSAIDs or corticosteroids.

4. Laboratory Monitoring

Regular blood tests are recommended to monitor for:

• Lymphocyte and neutrophil counts
• Hemoglobin levels
• Liver function tests (LFTs)
• Lipid profiles

Baseline and periodic monitoring is essential to detect potential hematologic or hepatic abnormalities.

5. Immunizations

• Live vaccines should not be administered during or shortly before treatment with tofacitinib.

Ensure all immunizations are up to date prior to initiating therapy.

✔️ Storage:

Store below 30°C. Protect from light & moisture. Keep all medicines out of the reach of children.