Description

What is Tofacitinib 11 mg?

Tofacitinib 11 mg is a specific dosage strength of the medication Tofacitinib. Tofacitinib is an oral Janus kinase (JAK) inhibitor used to treat various autoimmune conditions, including rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis, among others.

Recommended Tofacitinib Dosage

The dosage of Tofacitinib 11 mg can vary depending on the specific autoimmune condition being treated and the individual patient’s medical history. It is of utmost importance to adhere to the dosage and instructions provided by your healthcare provider. Typically, Tofacitinib tablet taken once daily.

Rheumatoid Arthritis: The usual starting dose is 5 mg taken orally twice daily (for a total of 10 mg per day). Some patients may be prescribed a higher dose, such as 11 mg once daily, depending on the severity of the condition and their response to treatment.

Psoriatic Arthritis: The typical starting dose is 5 mg taken orally twice daily (for a total of 10 mg per day). As with rheumatoid arthritis, some individuals may be prescribed tofacitinib 11 mg once daily.

Ulcerative Colitis

• The recommended starting dose for adults is often tofacitinib 10 mg taken orally twice daily for induction for 8 weeks and 11 mg given once daily for maintenance.
• For patients who do not achieve adequate therapeutic benefit by week 8, the induction dose of 10 mg twice daily can extend for an additional 8 weeks (16 weeks total), followed by 11 mg once daily for maintenance. Tofacinix 11 mg (Tofacitinib) induction therapy should discontinue in any patient who shows no evidence of therapeutic benefit by week 16.
• Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is half the total daily dose.

Warnings And Precautions

Serious and sometimes life-threatening infections have been reported in patients who are undergoing treatment with Tofacitinib. These infections can be caused by various pathogens, including bacteria, mycobacteria, invasive fungi, viruses, and other opportunistic microorganisms. Among the most frequently observed serious infections associated with Tofacitinib use are pneumonia, cellulitis, herpes zoster (shingles), urinary tract infections, diverticulitis, and appendicitis.

In addition to these common infections, Tofacinix has also been linked to opportunistic infections such as tuberculosis and other mycobacterial infections, cryptococcosis, histoplasmosis, esophageal candidiasis, pneumocystosis, multidermatomal herpes zoster, cytomegalovirus infections, BK virus infection, and listeriosis.

It’s worth noting that some patients have developed disseminated infections rather than localized ones. This has occurred more frequently in individuals who were also taking other immunomodulating drugs like methotrexate or corticosteroids alongside Tofacitinib.

In the case of patients with ulcerative colitis (UC), caution should be exercised when considering the use of Tofacinix. It is advisable to avoid Tofacinix in individuals with active and serious infections, including those that are localized. Before initiating Tofacitinib treatment, healthcare providers should carefully evaluate the potential risks and benefits, especially in patients who have:

• Chronic or recurrent infections.
• Been exposed to tuberculosis.
• Suffered from serious or opportunistic infections.
• Resided in or traveled to areas where tuberculosis or endemic fungal infections are prevalent.
• Underlying medical conditions that may make them more susceptible to infections.

Always follow your doctor’s instructions and attend regular check-ups while closely monitor for the development of signs and symptoms of infection during and after treatment with Tofacinix.

Side Effects

Most common side effects are:

• Upper respiratory tract infections
• Headache
• High blood pressure (hypertension)
• Increased levels of liver enzymes
• Nausea
• Diarrhea
• Changes in blood cell counts
• Elevated levels of cholesterol and triglycerides
• Skin rash
• Elevated creatinine levels (a marker of kidney function)

Pregnancy and Lactation

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Tofacinix uses during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this medicine is excreted in human milk. Caution exercised when this product administered to a nursing woman.

Tofacitinib Drug Interactions

With medicine: Tofacitinib exposure increase when Tofacitinib is co-administered with potent inhibitors of cytochrome P450 (CYP) 3A4 (e.g., ketoconazole) and CYP2C19 (e.g., fluconazole). Use of Tofacitinib in combination with biologic DMARDs or potent immune suppressants such as azathioprine and cyclosporine not recommend.

With food and others: Avoid taking Tofacitinib with grapefruit juice and to avoid grapefruit juice completely during Tofacitinib treatment.

Overdose

There is no specific antidote for overdose with Tofacitinib 11 mg. In case of an overdose, it recommends that the patient monitor for signs and symptoms of adverse reactions.

Storage Condition

Store Tofacinix (Tofacitinib) below 25°C. Do not remove desiccant. Dispense in the original container. Keep it out of the reach and sight of children.

How Supplied

Tofacinix tablet: Each HDPE container of Tofacinix contains 60 tablets, a silica gel desiccant, and a polyester coil with a child-resistant closure

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