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INTRODUCTION
TOFADOZ 10 TABLET contains Tofacitinib, which belongs to the group of medicines called Antirheumatics. It is used to treat inflammatory diseases such as rheumatoid arthritis (chronic inflammatory diseases affecting the joints, causing pain and swelling), psoriatic arthritis (an arthritic condition that occurs in an individual with psoriasis), ulcerative colitis (ulcerative inflammation of the digestive tract) and ankylosing spondylitis (fusion of bones in the spine).
TOFADOZ 10 TABLET is also used to treat polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis, which cause pain and inflammation of joints in children. TOFADOZ 10 TABLET is used alone or together with other drugs, such as methotrexate.
TOFADOZ 10 TABLET is not recommended for use in patients with severe liver diseases (including cirrhosis), bloodstream infections or active tuberculosis. TOFADOZ 10 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 at risk of developing a blood clot, are planning to get vaccinated, have undergone major surgery.
TOFADOZ 10 TABLET should not be used by pregnant or breastfeeding women. TOFADOZ 10 TABLET should be used with caution in patients over the age of 65. The safety and effectiveness of TOFADOZ 10 TABLET in children under the age of two have not yet been established.
Lung infection, sore throat, sinusitis, vomiting, nausea, diarrhoea, indigestion and headache are the most common side effects of TOFADOZ 10 TABLET. Ask for your doctor’s advice if any of these worsen or don’t improve.
USES OF TOFADOZ 10 TABLET
Treats inflammatory conditions such as:
- rheumatoid arthritis
- psoriatic arthritis
- ulcerative colitis
- ankylosing spondylitis
- polyarticular juvenile idiopathic arthritis
- juvenile psoriatic arthritis
HOW TOFADOZ 10 TABLET WORKS
TOFADOZ 10 TABLET helps in treating inflammatory diseases by modifying the immune system. It prevents the body from responding to these substances called cytokines (controls growth and activity of other immune system cells and blood cells). It also inhibits the inflammation process via a new pathway (Janus kinases).
DIRECTIONS FOR USE
Take TOFADOZ 10 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 TOFADOZ 10 TABLET for you depending on your age, disease condition and body weight.
SIDE EFFECTS OF TOFADOZ 10 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 enzyme,)
- 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 TOFADOZ 10 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, persistent headaches
- signs of ulcers or perforations in the stomach such as fever, stomach or abdominal pain, blood in the stool, unexplained changes in bowel habits
- signs of allergic reactions such as chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips, tongue or throat, hives (itching or skin rash)
- signs of blood clots in 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 such as severe chest pain or tightness (that may spread to arms, back, jaw, neck), shortness of breath, cold sweat, light-headedness or sudden dizziness
HOW TO MANAGE SIDE EFFECTS
Nausea:
Take this medicine with or just after meals. Stick to simple meals. Avoid eating rich or spicy food. Ask for your doctor’s advice if the nausea does not improve.
Vomiting:
Drink clear or ice-cold drinks, eat bland, light foods and avoid oily, fried or sweet foods. Ask for your doctor’s advice if vomiting does not improve.
Diarrhea:
Drink a lot of fluids, such as squash, water or fruit juice to keep yourself hydrated. Do not consume any medicine by yourself without consulting your physician. Ask for your doctor’s advice if the diarrhea does not improve.
Stomach pain:
Try to rest and relax. Try to have smaller and more frequent meals and eat and drink slowly. Keep a heating pad on your stomach. Ask for your doctor’s advice if stomach pain does not improve.
Headache:
Try to take rest and avoid involving yourself in exertive activities. Apply a pain-relieving balm on your forehead. Ask for your doctor’s advice if the headache does not improve.
WARNING & PRECAUTIONS
PREGNANCY
TOFADOZ 10 TABLET is not recommended for use in pregnant women or women planning to have a baby. If you are a woman of childbearing age, you should use effective birth control during treatment and for at least 4 weeks after the last dose. Consult your doctor before taking it.
BREASTFEEDING
TOFADOZ 10 TABLET is not recommended for use in breastfeeding women. Consult your doctor before taking it.
DRIVING AND USING MACHINES
TOFADOZ 10 TABLET does not affect your ability to drive or use machines.
KIDNEY
TOFADOZ 10 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
TOFADOZ 10 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 having other liver diseases such as hepatitis B or hepatitis C. Dose will be adjusted by your doctor. Consult your doctor before taking it.
ALLERGY
Do not take TOFADOZ 10 TABLET if you are allergic to Tofacitinib or any other ingredients of this medicine.
LUNGS
TOFADOZ 10 TABLET is not recommended for use in active tuberculosis.
TOFADOZ 10 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
TOFADOZ 10 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.
OTHERS
TOFADOZ 10 TABLET is not recommended for use if you have:
- severe bloodstream infection
Before taking TOFADOZ 10 TABLET inform your doctor if you have:
- infection, being treated 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, diarrhoea or stomach pain, problems with urination, tiredness)
- conditions that increase the chances of infections (Ex. diabetes, HIV/AIDS or a weak immune system)
- tendency of having infections/ 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
Use in paediatrics:
The safety and effectiveness of TOFADOZ 10 TABLET in children below 2 years of age have not been established yet. Consult with your doctor before taking it.
Use in geriatrics:
TOFADOZ 10 TABLET should be used with caution in patients above the age of 65 years of age as they may be at increased risk of infections, heart attack and some types of cancer. Consult with your doctor before taking it.
INTERACTIONS
A, Drug-Drug Interactions:
Before taking TOFADOZ 10 TABLET Inform your physician if you are taking any of the following medicines:
- antibiotics such as rifampicin (used in treating bacterial infections)
- fluconazole, ketoconazole (used to treat fungal infections)
- azathioprine, mercaptopurine, ciclosporin, tacrolimus (medicines that depress the immune system)
- corticosteroids such as prednisone (used in treating pain and inflammation)
Overdosage:
If you or anyone else accidentally take too much of TOFADOZ 10 TABLET, consult your doctor immediately or visit the nearby hospital.
SYNOPSIS
| Drug | : | Tofacitinib |
| Pharmacological Category | : | Janus Kinase Inhibitors |
| Therapeutic Indication | : | Inflammatory diseases |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep TOFADOZ 10 TABLET out of reach from children
- Store at below 30°C
FAQs ABOUT TOFADOZ 10 TABLET
What is TOFADOZ 10 TABLET and why is it prescribed?
TOFADOZ 10 TABLET contains tofacitinib, which belongs to the group of medicines called immunosuppressants. It is used to treat 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).TOFADOZ 10 TABLET is also used to treat polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis, which cause pain and inflammation of joints in children. TOFADOZ 10 TABLET is used together with drugs such as methotrexate when previous rheumatoid arthritis treatment was not sufficient or was not well tolerated.
What should I know before starting to take TOFADOZ 10 TABLET?
TOFADOZ 10 TABLET can lower the ability of your immune system to fight infections. Do not start stating TOFADOZ 10 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 TOFADOZ 10 TABLET.
Can TOFADOZ 10 TABLET be taken by pregnant or breastfeeding women?
TOFADOZ 10 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 treatment with TOFADOZ 10 TABLET and for at least 4 weeks after the last dose. Tell your doctor immediately if you become pregnant while taking TOFADOZ 10 TABLET. Consult your doctor before taking it.
Is TOFADOZ 10 TABLET used by children?
TOFADOZ 10 TABLET is used to treat 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.
Do I need to undergo routine diagnostic tests while taking TOFADOZ 10 TABLET?
Your doctor might check you regularly for the levels of white blood cells and red blood cells in your blood while you take TOFADOZ 10 TABLET. He must also check his cholesterol levels and liver and kidney functions regularly.
How do I manage if I forget to take a dose of TOFADOZ 10 TABLET?
If you forgot to take a dose of TOFADOZ 10 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 TOFADOZ 10 TABLET to make up for a forgotten dose. Consult your doctor for advice.
Can TOFADOZ 10 TABLET be used safely on elderly patients?
Patients aged 65 years and older may be at increased risk of infections, heart attacks and some types of cancer; therefore, TOFADOZ 10 TABLET should be used with caution in patients above the age of 65 years. Consult with your doctor before taking it.
REFERENCES
1. R.S Satoskar, Nirmala N. Rege, 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, 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 28th July 2022] 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 28th July 2022] https://pubmed.ncbi.nlm.nih.gov/29139090/
4. NIH National Library of Medicine, National center for biotechnology information. Pubchem. Tofacitinib. [Revised on September 2022] [Accessed on 28th July 2022] https://pubchem.ncbi.nlm.nih.gov/compound/Tofacitinib
5. Pfizer Manufacturing Deutschland GmbH. Electronic Medicines Compendium (EMC). [Revised in March 2022]. [Accessed on 28th July 2022] https://www.medicines.org.uk/emc/files/pil.2500.pdf
USEFUL DIAGNOSTIC TESTS
- X-ray
- MRI
- Complete Blood Count
- Skin test
- Liver/kidney function test
AUTHOR DETAILS
Written By Dr. Dhivakaran R, BDS
Last updated on 29 Nov 2022 | 02:14 PM(IST)
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