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Thalix 50mg Capsule 10'S

Auto Immune Disease
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    Introduction About THALIX 50MG CAPSULE

    THALIX 50MG CAPSULE contains Thalidomide which belongs to the group of medicines called Immunomodulating Agents. It is used in combination with other medicines (melphalan and prednisone) in the management of a type of cancer called Multiple Myeloma in patients below 65 years of age and have not been prescribed with any other medicine and in patients above 65 years of age who cannot tolerate high doses of chemotherapy.

    Multiple Myeloma is a certain type of cancer which affects a specific white blood cell called plasma cell.  

    Before starting the management with THALIX 50MG CAPSULE, your doctor might want you to take some diagnostic tests to understand your existing condition.

    Before taking THALIX 50MG CAPSULE, inform your doctor if you have or had liver, heart or kidney disease, high blood pressure, high cholesterol, blood clot, nerve damage, fall in number of white blood cells with fever and infection, severe skin infections, viral infections, or prone to bleeding and bruising.

    THALIX 50MG CAPSULE is not recommended for use in pregnant and breast-feeding women. Consult with your doctor before taking it.

    It should be used with caution in men as it passes through the semen. Men must not donate semen while getting managed with THALIX 50MG CAPSULE and should use effective contraception. THALIX 50MG CAPSULE should not be taken by children and adolescents below 18 years of age.

    The most common side effects of taking THALIX 50MG CAPSULE are constipation, dizziness, sleepiness, tiredness, shaking, abnormal sensations, swelling of hands and feet. Ask for your doctor’s advice if any of these worsen or doesn’t improve.

    Uses Of THALIX 50MG CAPSULE

    • Manage multiple myeloma (in combination with other medicines)

    How THALIX 50MG CAPSULE Works

    THALIX 50MG CAPSULE effectively helps in the management of multiple myeloma by helping the body’s immune system and inhibiting the production of a certain type of protein (Interleukin-6) which is responsible for the growth of cancer cells. THALIX 50MG CAPSULE also stops the development of blood vessels in the cancer cells and stimulates the immune system to kill the cancer cells.

    How to use THALIX 50MG CAPSULE

    Take THALIX 50MG CAPSULE as advised by your doctor. Swallow the medicine with a glass of water. Do not crush or chew the medicine. While handling THALIX 50MG CAPSULE you should wear disposable gloves. After that gloves should be carefully removed, avoiding contact of the capsule with the skin and should be properly disposed off covered in a sealable polyethene bag.

    If powder from a broken THALIX 50MG CAPSULE capsule comes in contact with the skin, wash the skin immediately and thoroughly with soap and water. Your doctor will decide the correct dose and duration of THALIX 50MG CAPSULE for you depending on your age, disease condition and body weight.

    Side Effects Of THALIX 50MG CAPSULE

    Common

    • constipation
    • feeling dizzy, sleepiness, feeling tired
    • shaking (tremor)
    • decreased or abnormal sensation (dysesthesia)
    • swelling of hands and feet
    • indigestion
    • nausea, vomiting
    • dry mouth
    • rash, dryness of the skin
    • feeling weak, faint or unsteady
    • lack of energy or strength
    • low blood pressure
    • fever, feeling generally unwell
    • convulsions
    • a spinning feeling in the head which causes difficulty in standing up and moving normally
    • blurred vision
    • chest infection, lung disease (chest pain while coughing or breathing, difficulty in breathing)
    • slow heart rate, heart failure
    • depression, confusion, mood changes, anxiety
    • hearing decreased or deafness

    Uncommon

    • inflammation and swelling of the tubes in the lungs (bronchitis)
    • inflammation of the cells lining the stomach wall (pain in the abdomen, feeling of fullness)
    • hole in the part of the large bowel (colon) which can cause infection
    • bowel obstruction
    • fall of blood pressure on standing that may cause fainting
    • heart block or atrial fibrillation (irregular heartbeat)

    Rare

    Stop taking THALIX 50MG CAPSULE and contact your doctor immediately if you experience any of the following side effects:  

    • signs of progressive multifocal leukoencephalopathy (PML) (blurred, loss of or double vision, weakness in an arm or a leg, difficulty speaking, changes in walking or problems with balance, decreased sensation or loss of sensation, persistent numbness, memory loss or confusion)
    • extremely intense and serious skin reactions appearing as rashes with or without blisters. Skin irritation, sores or swelling in the mouth, throat, eyes, nose and around the genitals, oedema, flu-like symptoms and fever
    • allergic reactions which may include localised or generalised pruritic rash, angioedema and anaphylactic reaction and appear as hives, rashes, swelling of eyes, mouth or face, the difficulty of breathing or itching
    • peripheral neuropathy (tingling, numbness, abnormal coordination or pain in hands and feet)
    • signs of pulmonary embolism, blood clot in lungs (sudden pain in chest or difficulty in breathing)
    • signs of blood clots in veins of the legs (pain or swelling in legs, especially in lower leg or calves)
    • signs of heart attack (chest pain spreading to the arms, neck, jaw, back or stomach, sweating, breathless, nausea, vomiting)
    • signs of stroke (temporary difficulty in seeing or speaking)
    • signs of infections (fever, sore throat, chills, cough, mouth ulcers)
    • bleeding or bruising without any injury

    How To Manage Side Effects

    Nausea:

    Take THALIX 50MG CAPSULE with or just after meals. Stick to simple meals. Avoid eating oil-rich or spicy foods. If the symptom does not improve, consult with your doctor.

    Vomiting:

    Drink clear or ice-cold drinks, eat light, bland foods and avoid eating fried, oily or sweet foods. If the symptom does not improve, consult with your doctor.

    Constipation:

    Eat plenty of fibre-rich foods such as vegetables, fresh fruits, cereals and drink plenty of water while taking THALIX 50MG CAPSULE. Exercise more regularly. If the symptom does not improve, consult with your doctor.

    Dry mouth:

    Sip water regularly and other sugar-free liquids. Do not use mouthwashes that contain alcohol because they can make your mouth dry, use mouthwash that is used only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco products. Consult your doctor if the symptom does not improve.

    Warning & Precautions

    Pregnancy

    THALIX 50MG CAPSULE is not recommended for use in pregnant women as it may increase the chances of serious birth defects in the baby such as shortened arms or legs, eye or ear defects, improperly formed hands or feet and problems with internal organs. Your doctor might ask you to take pregnancy tests regularly while getting managed with THALIX 50MG CAPSULE and even after the management stops. Consult your doctor before taking THALIX 50MG CAPSULE.

    Breastfeeding

    THALIX 50MG CAPSULE is not recommended for use in breastfeeding women as it is not known if it passes through the breast milk. Consult your doctor before taking THALIX 50MG CAPSULE.

    Driving and Using Machines

    Do not drive or operate any machines if you feel dizzy, tired, sleepy or blurring of vision after taking THALIX 50MG CAPSULE.

    Alcohol

    Avoid the consumption of alcohol while taking THALIX 50MG CAPSULE as it can make you sleepier.

    Kidney

    THALIX 50MG CAPSULE should be taken with caution in patients with kidney diseases. Consult your doctor before taking THALIX 50MG CAPSULE.

    Liver

    THALIX 50MG CAPSULE should be taken with caution in patients with liver problems or injuries (hepatic disorders) including abnormal liver function test. Consult your doctor before taking THALIX 50MG CAPSULE.

    Allergy

    Do not take THALIX 50MG CAPSULE if you are allergic to Thalidomide or any other ingredients of this medicine.

    Heart Disease

    THALIX 50MG CAPSULE should be taken with caution in patients with heart diseases such as history of heart attack, slow heart rate and high blood pressure. Consult your doctor before taking THALIX 50MG CAPSULE.

    Others

    Before taking THALIX 50MG CAPSULE, inform your doctor if you:

    • have or had a blood clot
    • have high levels of cholesterol
    • have existing nerve damage (tingling, abnormal co-ordination or pain in hands or feet)
    • have high blood pressure in arteries of the lungs (blue lips and skin, chest pressure or pain, dizziness or fainting, fast pulse or heartbeat, fatigue, shortness of breath, swelling in the ankles, legs and abdomen)
    • have reduced number of platelets (increased bleeding and bruising)
    • have reduced number of white blood cells (fever, infection)
    • have had sleepiness
    • have or ever had a viral infection (Ex. varicella zoster, hepatitis B infection, HIV)
    • have had serious skin reactions
    • are a male and has a partner who has the potential to become pregnant as THALIX 50MG CAPSULE passes through semen

    Use in paediatrics:

    THALIX 50MG CAPSULE is not recommended for use in children and adolescents (aged below 18 years of age). Consult your child’s doctor for advice.

     Use in geriatrics:

    Your doctor will advise the correct dose and duration of THALIX 50MG CAPSULE for you depending on your age, disease condition and body weight.

    Interactions

    A. Drug – Drug Interactions:

    Before taking THALIX 50MG CAPSULE, inform your doctor if you are taking any of the following medicines:

    • sedatives such as anxiolytics (Ex. diazepam, clonazepam), hypnotics (Ex. estazolam), antipsychotics (Ex. clozapine), opiate derivatives (Ex. fentanyl), barbiturates (Ex. phenobarbital)
    • H1 antihistamines (Ex. chlorpheniramine) (used to manage allergies)
    • anticholinesterases (Ex. neostigmine), beta-blockers (Ex. propranolol) (used to slow down the heart rate)
    • digoxin (used for managing heart problems)
    • warfarin (used for thinning the blood)
    • vincristine, oxaliplatin (used for managing for cancer and may cause neuropathy)
    • estradiol (used for contraception)

    Overdosage:

    If you or anyone else accidentally take too much of THALIX 50MG CAPSULE, consult your doctor immediately or visit the nearby hospital. The symptoms of overdosage of THALIX 50MG CAPSULE are numbness and tingling in hands or feet, excessive sleepiness, constipation, dry mouth, skin rash and weakness.

    Synopsis

    Drug :   Thalidomide
    Pharmacological Category :   Immunomodulating Agents
    Therapeutic Indication :   Multiple Myeloma
    Dosage Forms :   Capsule

    More Information

    • Keep THALIX 50MG CAPSULE out of reach of children
    • Store at room temperature

    FAQs About THALIX 50MG CAPSULE

    What is THALIX 50MG CAPSULE and why is it given?

    THALIX 50MG CAPSULE contains Thalidomide which belongs to the group of medicines called Immunomodulating Agents. It is used with other medicines in the management of a type of cancer called Multiple Myeloma in patients below 65 years of age and have not been prescribed any other medicine and in patients above 65 years of age who cannot tolerate high doses of chemotherapy.

    Can I donate blood while taking THALIX 50MG CAPSULE?

    No, you must not donate blood while getting managed with THALIX 50MG CAPSULE and for at least 7 days after stopping the management. This is because THALIX 50MG CAPSULE has dose-dependent effects and can cause serious birth defects in babies or even foetal death. Consult your doctor before donating.

    How to manage if I forget to take a dose of THALIX 50MG CAPSULE?

    If you forget to take a dose of THALIX 50MG CAPSULE at your regular time and less than 12 hours have passed, then take THALIX 50MG CAPSULE immediately. If it has been more than 12 hours, do not take the missed dose, take your next dose at the same time of the day.

    What precautions do men need to follow while taking THALIX 50MG CAPSULE?

    If you are a man taking THALIX 50MG CAPSULE and have a partner who has the potential to become pregnant, make sure that you use effective methods of contraception as THALIX 50MG CAPSULE passes into the semen. You must not donate semen while on management with THALIX 50MG CAPSULE. Consult with your doctor for advice

    What all parameters need to be monitored while taking THALIX 50MG CAPSULE?

    While taking THALIX 50MG CAPSULE, your doctor might monitor your thyroid gland functioning, the number of tumours in the body and your blood cell count as it is important to keep a check on all of these. Consult with your doctor for advice before taking this medicine.

    What precautions should be followed while taking THALIX 50MG CAPSULE?

    While handling THALIX 50MG CAPSULE you should wear disposable gloves. After that gloves should be carefully removed, avoiding contact of the capsule with the skin and should be properly disposed of covered in a sealable polyethene bag. If powder from a broken THALIX 50MG CAPSULE capsule comes in contact with the skin, wash the skin immediately and thoroughly with soap and water.

    References

    1. KD. Tripathi. Anticancer Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 877.

    2. Irene M. Ghobrial, S. Vincent Rajkumar. Management of Thalidomide Toxicity. NIH National Library of Medicine, National center for biotechnology information. Pubmedcentral. October 2003. [Accessed on 20th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3134146/

    3. Christian D.K. Becker, Dirk O. Stichtenoth, Michael G. Wichmann, Christof Schaefer, Ladislaus Szinicz. Blood Donors on Medication – an Approach to Minimize Drug Burden for Recipients of Blood Products and to Limit Deferral of Donors. NIH National Library of Medicine, National center for biotechnology information. Pubmedcentral. March 2009. [Accessed on 20th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2928823/

    4. NIH National Library of Medicine, National center for biotechnology information. Pubchem. Thalidomide. [Accessed on 20th June 2022] https://pubchem.ncbi.nlm.nih.gov/compound/Thalidomide

    5. Celgene Distribution B.V. Electronic Medicines Compendium (EMC). [Revised in Feb 2022]. [Accessed on 20th June 2022] https://www.medicines.org.uk/emc/files/pil.6317.pdf

    Useful Diagnostic Tests

    • Complete Blood Count
    • Bone Marrow Biopsy
    • Bone Xray

    Author Details

    Written By Dr. R. Dinesh John Rajkumar - Pharm.D
    Reviewed For Accuracy By Dr. M N Himaja - MBBS
    Last updated on 05 Dec 2022 | 02:56 PM(IST)
    Lab updated