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Introduction About TOFASURE XR TABLET
TOFASURE XR TABLET is used to manage inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis. TOFASURE XR TABLET is also used to manage polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis, which cause pain and inflammation of joints in children.
TOFASURE XR TABLET contains Tofacitinib, which belongs to the group of medicines called Antirheumatics. It prevents the body from responding to these substances called cytokines (which control the growth and activity of other immune system cells and blood cells). It also inhibits the inflammation process via a new pathway (Janus kinases).
TOFASURE XR TABLET is used alone or together with other drugs, such as methotrexate. Take TOFASURE XR TABLET as advised by your physician. Swallow the medicine with a glass of water. It can also be crushed and taken with water. Do not chew the medicine.
TOFASURE XR TABLET is not recommended for use in patients with severe liver diseases (including cirrhosis), bloodstream infections, or active tuberculosis. TOFASURE XR TABLET should be used with caution in patients who have an infection or a condition that increases their risk of infection (for example, diabetes, HIV/AIDS, or a weak immune system), chronic lung disease, tuberculosis, hepatitis B or C, liver, kidney, or heart diseases, cancer or are at risk of developing skin cancer, smoking habits, lactose intolerance, inflammation of the large intestine, stomach or intestine ulcers, blood pressure, high cholesterol, or are at risk of developing a blood clot, are planning to get vaccinated, or have undergone major surgery.
TOFASURE XR TABLET should not be used by pregnant or breastfeeding women. TOFASURE XR TABLET should be used with caution in patients over the age of 65. The safety and effectiveness of TOFASURE XR TABLET in children under the age of two have not yet been established.
Lung infection, sore throat, sinusitis, vomiting, nausea, diarrhea, indigestion, and headache are the most common side effects of TOFASURE XR TABLET. Ask for your doctor’s advice if any of these worsen or don’t improve.
Uses Of TOFASURE XR TABLET
Manages inflammatory conditions such as:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ulcerative colitis
- Ankylosing spondylitis
- Polyarticular juvenile idiopathic arthritis
- Juvenile psoriatic arthritis
How TOFASURE XR TABLET Works
TOFASURE XR TABLET helps in managing inflammatory diseases by modifying the immune system. It prevents the body from responding to these substances called cytokines (which control the growth and activity of other immune system cells and blood cells). It also inhibits the inflammation process via a new pathway (Janus kinases).
How to use TOFASURE XR TABLET
Take TOFASURE XR TABLET as advised by your physician. Swallow the medicine with a glass of water. It can also be crushed and taken with water. Do not chew the medicine. Your doctor will decide the correct dose and duration of TOFASURE XR TABLET for you depending on your age, disease condition, and body weight.
Side Effects Of TOFASURE XR TABLET
Common
- Lung infection such as pneumonia or bronchitis
- Shingles (herpes zoster)
- Nasopharyngitis (infections of the nose, throat, or windpipe)
- Influenza
- Sinusitis
- Urinary bladder infection
- Sore throat
- Signs of muscle problems
- Stomach pain (possibly due to inflammation of the stomach lining)
- Vomiting, nausea
- Diarrhoea
- Indigestion
- Anaemia
- Fever, fatigue
- Swelling of the feet and hands
- Headache
- High blood pressure
- Cough
- Rash
Uncommon
- Tuberculosis
- Signs of kidney problems (blood creatinine increase)
- Skin infection, skin redness, itching
- Cold sores (tiny, painful blisters at the border of the lip)
- Low white blood cells
- Signs of liver problems (increase in liver enzymes)
- Increased cholesterol
- Weight gain
- Dehydration
- Muscle strain
- Pain in the muscles and joints; tendonitis (inflammation of tendons)
- Joint swelling and sprain
- Abnormal sensations
- Poor sleep
- Sinus congestion
- Shortness of breath or difficulty breathing
- Fatty liver
- Painful inflammation of small pockets in the lining of your intestine (diverticulitis)
- Viral infections: viral infections affecting the digestive tract
- Some types of skin cancers (non-melanoma types)
- Lung cancer
Rare
- Blood infection (sepsis)
- Lymphoma (white blood cell cancer)
- Disseminated tuberculosis involving bones and other organs
- Other unusual infections
- Joint infections
Stop taking TOFASURE XR TABLET and inform your doctor immediately if you experience any of the following side effects:
- Signs of serious infections such as fever and chills, cough, skin blisters, stomach pain, and persistent headaches
- Signs of ulcers or perforations in the stomach, such as fever, stomach or abdominal pain, blood in the stool, or unexplained changes in bowel habits
- Signs of allergic reactions such as chest tightness, wheezing, severe dizziness or lightheadedness, swelling of the lips, tongue, or throat, and hives (itching or skin rash)
- Signs of blood clots in the lungs or veins, such as sudden shortness of breath or difficulty breathing, leg pain or tenderness, chest pain or pain in the upper back, swelling of the leg or arm, redness or discolouration in the leg or arm
- Signs of a heart attack may include severe chest pain or tightness (that may spread to the arms, back, jaw, and neck), shortness of breath, cold sweat, lightheadedness, or sudden dizziness.
How To Manage Side Effects
Diarrhea
Drink plenty of clear fluids, like water, diluted fruit juices, or oral rehydration solutions, to stay hydrated. Avoid alcohol, caffeine, and very sugary drinks, as they can worsen dehydration. Eat bland foods like bananas, rice, applesauce, and toast. These are easy to digest and can help firm up the stools. Probiotics, found in yogurt or supplements, may help restore the balance of gut bacteria. Practice good hand hygiene to prevent the spread of infection. Consult your doctor if diarrhea worsens.
Headache
Ensure adequate fluid intake, as dehydration can cause headaches. Maintain a consistent sleep schedule, aiming for 7-9 hours of quality sleep per night. Eat balanced meals at regular intervals to avoid blood sugar fluctuations that can trigger headaches. Practice relaxation techniques such as meditation, yoga, or deep breathing exercises to reduce stress levels. Engage in regular physical exercise, which can help reduce the frequency and severity of headaches. Apply a cold pack or warm compress to the forehead or neck to alleviate pain. Consult your doctor if a headache persists.
Nausea And Vomiting
Eating small amounts more frequently can help prevent the stomach from becoming too full and reduce nausea. Opt for bland, easy-to-digest foods like crackers, toast, rice, bananas, and applesauce. Avoid strong smells and spicy foods, as they can trigger or worsen nausea. Sip on clear liquids like water, broth, or herbal teas. Electrolyte solutions can be beneficial if nausea is accompanied by vomiting.
Stomach Pain
Avoid spicy or fatty foods, caffeine, or alcohol that may exacerbate symptoms. Eat a bland diet consisting of easily digestible foods like rice, bananas, applesauce, and toast. Applying a heating pad or taking a warm bath can also help soothe abdominal muscles and alleviate discomfort. Drink plenty of fluids to stay hydrated but avoid excessive consumption to prevent further irritation. If stomach pain persists, consult your doctor.
Warning & Precautions
Pregnancy
ContraindicatedTOFASURE XR TABLET is not recommended for use by pregnant women or women planning to have a baby. If you are a woman of childbearing age, you should use effective birth control during management and for at least 4 weeks after the last dose. Consult your doctor before taking it.
Breastfeeding
ContraindicatedTOFASURE XR TABLET is not recommended for use in breastfeeding women. Consult your doctor before taking it.
Driving and Using Machines
SafeTOFASURE XR TABLET does not affect your ability to drive or use machines.
Kidney
Use with CautionTOFASURE XR TABLET should be taken with caution in patients with kidney disease. The dose will be adjusted by your doctor. Consult your doctor before taking it.
Liver
Consult your doctorTOFASURE XR TABLET is not recommended in patients with severe liver problems such as cirrhosis (scarring of the liver). It should be used with caution in patients with other liver diseases, such as hepatitis B or hepatitis C. The dose will be adjusted by your doctor. Consult your doctor before taking it.
Allergy
ContraindicatedDo not take TOFASURE XR TABLET if you are allergic to Tofacitinib or any other ingredients in this medicine.
Lungs
Consult your doctorTOFASURE XR TABLET is not recommended for use in active tuberculosis.
TOFASURE XR TABLET should be taken with caution in patients with chronic lung disease or a history of tuberculosis. Consult your doctor before taking it.
Heart Disease
Use with CautionTOFASURE XR TABLET should be taken with caution in patients with heart diseases such as heart attack and high blood pressure. Consult your doctor before taking it.
Use In Pediatrics
Consult your doctorThe safety and effectiveness of TOFASURE XR TABLET in children below 2 years of age have not been established yet. Consult with your doctor before taking it.
Use In Geriatrics
Use with CautionTOFASURE XR TABLET should be used with caution in patients over the age of 65, as they may be at increased risk of infections, heart attacks, and some types of cancer. Consult with your doctor before taking it.
Others
TOFASURE XR TABLET is not recommended for use if you have:
- Severe bloodstream infection
Before taking TOFASURE XR TABLET, inform your doctor if you have:
- Infection, being managed for an infection or having symptoms of it (fever, sweating, chills, muscle aches, cough, shortness of breath, phlegm, weight loss, warm or red or painful sores, difficulty or painful swallowing, diarrhea or stomach pain, problems with urination, tiredness)
- Conditions that increase the chances of infection (Ex. diabetes, HIV/AIDS, or a weak immune system)
- Tendency of having infections or recurrent infections
- Cancer or at risk of developing cancer, especially skin cancer
- Habit of smoking
- Lactose intolerance
- Inflammation of the large intestine (diverticulitis)
- Stomach or intestine ulcers
- High cholesterol
- Risk of developing blood clots (seriously overweight, cancer, heart problems, diabetes)
- Plans for getting vaccinated
- Have undergone a major surgery
Interactions
A. Drug-Drug Interactions:
- Antibiotics (such as rifampicin)
- Antifungals (Ex. fluconazole, ketoconazole)
- Immunosuppressants (Ex. azathioprine, mercaptopurine, ciclosporin, and tacrolimus)
- Corticosteroids (such as prednisone)
Overdosage:
If you or anyone else accidentally takes too much TOFASURE XR TABLET, consult your doctor immediately or visit a nearby hospital.
Synopsis
| Drug | : | Tofacitinib |
| Pharmacological Category | : | Janus kinase inhibitors |
| Therapeutic Indication | : | Inflammatory diseases |
| Dosage Forms | : | Tablet |
More Information
Storage
- Keep TOFASURE XR TABLET out of reach of children
- Store below 30°C
FAQs About TOFASURE XR TABLET
Q: What is TOFASURE XR TABLET, and why is it prescribed?
A: TOFASURE XR TABLET contains tofacitinib, which belongs to the group of medicines called immunosuppressants. It is used to manage inflammatory diseases such as rheumatoid arthritis (chronic inflammatory diseases of the joints that cause pain and swelling), psoriatic arthritis (arthritis that affects people who have psoriasis), ulcerative colitis (inflammation and ulcers in the digestive tract), and ankylosing spondylitis (inflammatory disease that causes the bones in the spine to fuse). TOFASURE XR TABLET is also used to manage polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis, which cause pain and inflammation of joints in children. TOFASURE XR TABLET is used together with drugs such as methotrexate when previous rheumatoid arthritis management was not sufficient or was not well tolerated.
Q: What should I know before starting to take TOFASURE XR TABLET?
A: TOFASURE XR TABLET can lower the ability of your immune system to fight infections. Do not start stating TOFASURE XR TABLET if you have any kind of infection, a history of infection, or are at risk of developing one. Consult with your doctor before taking TOFASURE XR TABLET.
Q: Can TOFASURE XR TABLET be taken by pregnant or breastfeeding women?
A: TOFASURE XR TABLET is not recommended for use by pregnant or breastfeeding women. If you are a woman of childbearing age, effective birth control methods must be used during management with TOFASURE XR TABLET and for at least 4 weeks after the last dose. Tell your doctor immediately if you become pregnant while taking TOFASURE XR TABLET. Consult your doctor before taking it.
Q: Is the TOFASURE XR TABLET used by children?
A: TOFASURE XR TABLET is used to manage polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis, which cause pain and inflammation of joints in children over 2 years of age. Ask for your doctor’s advice before giving it to your child.
Q: Do I need to undergo routine diagnostic tests while taking TOFASURE XR TABLET?
A: Your doctor might check you regularly for the levels of white blood cells and red blood cells in your blood while you take TOFASURE XR TABLET. He must also check his cholesterol levels and liver and kidney functions regularly.
Q: How do I manage if I forget to take a dose of TOFASURE XR TABLET?
A: If you forgot to take a dose of TOFASURE XR TABLET, then do not take the missed dose between meals. Continue taking your medication as usual until your next scheduled dose and meal. Do not take a double dose of TOFASURE XR TABLET to make up for a forgotten dose. Consult your doctor for advice.
Q: Can TOFASURE XR TABLET be used safely on elderly patients?
A: Patients aged 65 years and older may be at increased risk of infections, heart attacks, and some types of cancer; therefore, TOFASURE XR TABLET should be used with caution in patients above the age of 65 years. Consult with your doctor before taking it.
Q: What does TOFASURE XR TABLET contain?
A: TOFASURE XR TABLET contains Tofacitinib, which belongs to the group of medicines called Antirheumatics.
Q: How does TOFASURE XR TABLET work?
A: TOFASURE XR TABLET helps in managing inflammatory diseases by modifying the immune system. It prevents the body from responding to these substances called cytokines (which control the growth and activity of other immune system cells and blood cells). It also inhibits the inflammation process via a new pathway (Janus kinases).
Q: What are the side effects of taking TOFASURE XR TABLET?
A: The most common side effects of taking TOFASURE XR TABLET are lung infection, sore throat, sinusitis, vomiting, nausea, diarrhea, indigestion, and headache. Consult your doctor if any of the side effects worsen.
References
1. R.S Satoskar, Nirmala N. Rege, and S.D. Bhandarkar. Pharmacotherapy of Rheumatoid Arthritis. Pharmacology and Pharmacotherapeutics. Twenty-Fourth Edition. 2015. Page – 1637.
2. Kucharz EJ, Stajszczyk M, Kotulska-Kucharz A, Batko B, Brzosko M, Jeka S, Leszczynski P, Majdan M, Olesinska M, Samborski W, and Wiland P. Tofacitinib in the treatment of patients with rheumatoid arthritis: position statement of experts of the Polish Society for Rheumatology. Reumatologia. NIH National Library of Medicine, National Center for Biotechnology Information. Pubmed. 2018. [Accessed on 14th June 2024] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6142023/
3. Sohita Dhillon. Tofacitinib: A Review in Rheumatoid Arthritis. NIH, National Library of Medicine, National Center for Biotechnology Information. PubMed. 2017. [Accessed on 14th June 2024] https://pubmed.ncbi.nlm.nih.gov/29139090/
4. NIH, National Library of Medicine, National Center for Biotechnology Information. PubChem. Tofacitinib. [Revised in September 2022] [Accessed on 14th June 2024] https://pubchem.ncbi.nlm.nih.gov/compound/Tofacitinib
5. Pfizer Manufacturing Deutschland GmbH. Electronic Medicines Compendium (EMC). [Revised in March 2022]. [Accessed on 14th June 2024] https://www.medicines.org.uk/emc/files/pil.2500.pdf
Useful Diagnostic Tests
- Complete Blood Count (CBC)/ Hemogram
- Liver Function Test (LFT)
- Kidney Function Test (KFT)
- Tuberculosis - Gamma Interferon - Quantiferon (T.B Gold)
- Infection Checkup Profile
- Tb - Whole Genome Sequencing
- Afb-Detection By Smear Examination Zn Stain, Sputum
- Lipid Profile Test/Cholesterol-Total, Serum
- Men Health Checkup – Advanced
- Complete Women Checkup
- Healthy Midlife Checkup
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