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Tofacent XR
Incepta Pharmaceuticals Ltd.
Generic: Tofacitinib
Safety Advices
বাংলা
English
SAFE
Consuming alcohol with Tofacent XR does not cause any harmful side effects.
CONSULT YOUR DOCTOR
Tofacent XR may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
CONSULT YOUR DOCTOR
Tofacent XR is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.
SAFE
Tofacent XR does not usually affect your ability to drive.
Medicine Overview of Tofacent XR 11mg Tablet
Introduction
Tofacent XR is used to treat moderate to severe rheumatoid arthritis. It helps decrease pain, tenderness and swelling in the joints by reducing inflammation. It also helps slow the progression of bone and joint damage. Tofacent XR may be prescribed by itself or in combination with another medicine. The tablets can be taken with or without food and it is best to take them at the same time each day. Your dose will depend on your condition and what other medicines you are taking. You should use it as your doctor tells you to. Do not stop taking this medicine...
... Show moreUses of Tofacent XR
- Rheumatoid arthritis
Side effects of Tofacent XR
Common
- Diarrhea
- Headache
- High blood pressure
- Nasal congestion (stuffy nose)
- Runny nose
- Sore throat
- Upper respiratory tract infection
How to use Tofacent XR
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Tofacent XR may be taken with or without food, but it is better to take it at a fixed time.
How Tofacent XR works
Tofacent XR is an Janus kinase inhibitor. It works by blocking the action of the enzyme, Janus kinase. This decreases inflammation and joint damage in rheumatoid arthritis.
Quick Tips
- Tofacent XR is used alone or in combination with other medicines for the treatment of rheumatoid arthritis, that did not improve with other anti-rheumatic drugs.
- It may take take 3 to 6 months to feel the maximum effect of this medication. Keep taking it as prescribed.
- Your doctor may get regular blood tests done to monitor your liver function, kidney function, blood counts, or cholesterol levels.
- Tofacent XR can make it a bit harder for people to fight off infections. Inform your doctor if you have symptoms of an infection such as fever, chills, cough, and muscle aches.
- Your doctor may get TB (tuberculosis) skin test and a chest X-ray before starting treatment with this medication.
- Inform your doctor if you are pregnant, planning to conceive, or breastfeeding.
Brief Description
Indication
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).
Administration
May be taken with or without food.
Adult Dose
Rheumatoid Arthritis
Indicated as second-line treatment for moderate-to-severe active rheumatoid arthritis in patients with an inadequate response or intolerance to methotrexate; may be used as monotherapy or in combination with methotrexate or other nonbiologic DMARDs
Adult: Recommended Dose: 5 mg twice daily.
Hepatic impairment
Mild: No dosage adjustment required
Moderate: Not to exceed 5 mg qDay
Severe: Not recommended
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment
Mild: No dosage adjustment required
Moderate-to-severe: Not to exceed 5 mg qDay
Contraindication
Hypersensitivity to the active substance or to any of the excipients.
Mode of Action
Janus kinases (JAKs) pathways inhibitor; JAK consists of a group of intracellular tyrosine kinases that transmit signals from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoieses and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs) which modulate intracellular activity including gene expression; tofacitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs. These signals are essential in maintaining the inflammatory condition in rheumatoid arthritis (RA); inhibition of JAKs reduces production of and modulates proinflammatory cytokines central...
... Show morePrecaution
Serious Infections – Do not administer Tofacitinib during an active infection, including localized infections. If a serious infection develops, interrupt Tofacitinib until the infection is controlled. Lymphomas and other malignancies have been reported in patients treated with Tofacitinib Gastrointestinal Perforations – Use with caution in patients that may be at increased risk. Laboratory monitoring –Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids. Immunizations –Live vaccines should not be given concurrently with Tofacitinib Do not initiate therapy in patients w/ an active infection including localized infections, chronic or recurrent infections, or those who have been exposed...
... Show moreSide Effect
>10%
Overall infections (20-22%)
1-10%
URTI (4.5%),Headache (4.3%),Diarrhea (4%),Nasopharyngitis (3.8%),UTI (2%),Hypertension (1.6%)
<1%
ANC <500/mm³ (0.07%),Lymphocytes <500/mm³ (0.04%)
Frequency Not Defined
Serious infections: 1.7 events per 100 patient-years
Malignancies: 0.3 events per 100 patient-years
Pregnancy Category Note
Pregnancy There is a pregnancy exposure registry that monitors pregnancy outcomes in women during pregnancy; patients can call the toll free number 1-877-311-8972 There are no adequate and well-controlled studies therapy in pregnant women In the tofacitinib clinical development programs, birth defects and miscarriages were reported Animal data Based on animal studies, tofacitinib has the potential to affect a developing fetus Based on findings in rats, females of reproductive potential taking tofacitinib may result in reduced fertility Contraception Advise females of reproductive potential to use effective contraception during treatment and for >4 weeks after the last dose Advise females to...
... Show moreInteraction
Increased exposure w/ potent CYP3A4 inhibitors (eg, ketoconazole), moderate CYP3A4 inhibitors & potent CYP2C19 inhibitors (eg, fluconazole). Decreased exposure w/ potent CYP inducers (eg, rifampin). Increased AUC & decreased Cmax w/ tacrolimus & cyclosporine. Decreased AUC & Cmax of MTX.
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