Description

Generic Name: Tofacitinib

Manufacturer : Incepta Pharmaceuticals Limited

Composition

Tofacent 5: Each tablet contains Tofacitinib Citrate INN equivalent to Tofacitinib 5 mg

Tofacent XR 11: Each Extended Release tablet contains Tofacitinib Citrate INN equivalent to Tofacitinib 11 mg.

 

What is Tofacitinib?

Tofacitinib sold under the brand name Xeljanz, is a type of drug known as a Janus kinase (JAK) inhibitor. Tofacitinib is a medication used to treat autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polyarticular course juvenile idiopathic arthritis, and ulcerative colitis.

It works by inhibiting certain enzymes in the body that are involved in the immune system’s response, thereby reducing inflammation and symptoms associated with these conditions.

 

Tofacent used for?

Rheumatoid Arthritis: It’s used in adults with moderately to severely active rheumatoid arthritis who didn’t respond well to methotrexate. It can be used alone or with methotrexate or other similar drugs.

Psoriatic Arthritis: It’s used in adults with active psoriatic arthritis who didn’t respond well to methotrexate or similar drugs.

Ulcerative Colitis: It’s used in adults with moderately to severely active ulcerative colitis.

Limitations: Avoid using it with biologic DMARDs or strong immunosuppressants like Azathioprine and cyclosporine.

 

Dosage And Administration

Administration

Before starting Tofacitinib 5 mg or Tofacitinib XR, ensure that the patient’s absolute lymphocyte count is at least 500 cells/mm3, absolute neutrophil count (ANC) is at least 1000 cells/mm3, and hemoglobin level is at least 9 g/dL.

 

Recommended Dosage

For Rheumatoid Arthritis recommended dosage is either Tofacitinib 5 mg twice daily or Tofacitinib XR 11 mg once daily. Patients with moderate to severe renal impairment or moderate hepatic impairment should take Tofacitinib 5 mg once daily.

 

For Psoriatic Arthritis with nonbiologic DMARDs, the dosage is the same as for Rheumatoid Arthritis. If the patient has moderate to severe kidney or liver issues, they should take Tofacitinib 5 mg tablet once daily.

 

For Ulcerative Colitis, start with Tofacitinib 10 mg twice daily or Tofacitinib XR 22 mg once daily for 8 weeks. Then, check how the patient is doing and switch to a maintenance dose depending on their response. If needed, they can keep taking the starting dose for up to 16 weeks. If the treatment isn’t working well enough, stop it.

 

Common Side Effects of Tofacent

Rheumatoid and Psoriatic Arthritis:

• Upper respiratory tract infection
• Nasopharyngitis
• Diarrhea
• Headache

Ulcerative Colitis

• Nasopharyngitis
• Elevated cholesterol levels
• Headache
• Upper respiratory tract infection
• Increased blood creatine phosphokinase
• Rash
• Diarrhea
• Herpes zoster

Precaution

If you are allergic to tofacitinib or have any other allergies, tell your doctor or pharmacist. The product may contain inactive ingredients, which can cause allergic reactions. Consult your pharmacist for more information.

 

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (such as in the lungs and legs), blood/bone marrow disorders (such as anemia, low lymphocyte/neutrophil count), cancer, heart problems (such as previous heart attack), kidney disease, liver disease (such as hepatitis B or C), lung disease, past/recent/current infections (such as tuberculosis, herpes zoster, HIV infection), current or past smoking, other stomach/intestinal disorders (such as ulcers, diverticulitis), stroke.

 

Tofacitinib tablets can increase your risk of getting infected or worsen an existing infection. Contact with people who have infections that can spread to others (such as chickenpox, measles, and the flu) should be avoided. For more information or consult your doctor if you have been exposed to an infection.

 

Vaccine

Before receiving any immunizations or vaccinations, inform your health care provider that you are using tofacitinib. It would be best to avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
Diabetes, liver disease, phenylketonuria (PKU), or any other condition requiring dietary limitations or avoidance is advised. If you have questions about using this product safely, consult your physician.

 

If you plan on having surgery, tell your doctor about all the medications you are taking (including prescriptions, non-prescription, and herbal products). Using this medication may increase the risk of infection for older adults.

 

Use in Pregnancy & Lactation

This medication should only be used when necessary during pregnancy. Consult your doctor about the risks and benefits. Let your doctor know if you intend to become pregnant or if you are already pregnant.

It is unknown whether this medication passes into breast milk. The use of this drug while breastfeeding and for at least 18 hours after the last dose is not recommended due to the potential risk to the infant. Before breastfeeding, consult your doctor.

 

Storage

Do not store above 30 0C. Keep away from light and out of the reach of children.

 

Countries where our service provided

Delivering worldwide including United State (USA), United Kingdom (UK), Saudi Arabia, Dubai, Kuwait, Qatar, Philippines, Nepal, Malaysia, Indonesia, Thailand, Poland, Peru, South Korea, New Zealand, Netherlands, Georgia, France, Egypt, Australia, Germany, Canada, Uzbekistan, Lebanon, Mexico, Singapore, Vietnam,  Pakistan, Russia, Ukraine, Bangladesh, India.

 

Note: The descriptions provided above are taken from the prescription information for Tofacent (Tofacitinib), as provided by Incepta Pharmaceuticals Limited. Full prescription