RITUXIREL 500mg Injection 50ml

INTRODUCTION

RITUXIREL 500MG INJECTION contains Rituximab which belongs to the group of medicines called Anticancer drugs. It is used to treat blood cancer (leukaemia) and lymph cancer (lymphoma). It can also be used to treat various auto-immune disease conditions such as rheumatoid arthritis, granulomatosis with polyangiitis or microscopic polyangiitis (inflammation of blood vessels) and pemphigus vulgaris (severe skin blistering and peeling especially on the mouth, nose, throat, eyes and genitals).

It is mostly used in combination with other cytotoxic anticancer agents to achieve better results. It is suitable for use both in adults and in children (aged 6 months or older). RITUXIREL 500MG INJECTION will be administered to you only by an oncologist or a trained professional into your vein (as intravenous infusion).

Before receiving RITUXIREL 500MG INJECTION inform your doctor if you have any heart problems (such as chest pain, heart attack, heart failure or abnormal heartbeat). You must also inform your doctor if you currently have or previously had hepatitis B infection or any other mild infections (including minor cough and cold) as a precaution.

RITUXIREL 500MG INJECTION is not recommended for use in pregnant or breastfeeding women. Both men and women receiving RITUXIREL 500MG INJECTION must use a suitable contraceptive method to avoid pregnancy while undergoing therapy with RITUXIREL 500MG INJECTION.

The most common side effects of receiving this medicine are fever, chills, skin rashes with itching, shortness of breath and low blood pressure. Consult your doctor if any of these side effect worsens.

USES OF RITUXIREL 500MG INJECTION

It is used to treat:

• Blood cancer (Chronic lymphocytic leukaemia)
• Lymph cancer (Non-Hodgkin’s Lymphoma)
• Rheumatoid arthritis (joint pain and inflammation)
• Granulomatosis with polyangiitis or microscopic polyangiitis (inflammation of blood vessels)
• Pemphigus vulgaris (severe skin blistering and peeling especially on the mouth, nose, throat, eyes and genitals)

HOW RITUXIREL 500MG INJECTION WORKS

RITUXIREL 500MG INJECTION is a monoclonal antibody. It destroys the immune cells (B-cells) that triggers cancer formation. It also reduces the production of certain chemicals within the body (such as rheumatoid factor, T-cells, cytokines) that causes inflammation, pain and swelling which helps in treating various autoimmune diseases.

DIRECTIONS FOR USE

RITUXIREL 500MG INJECTION will be given to you only by a doctor or a nurse into the vein (intravenously).

Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF RITUXIREL 500MG INJECTION

HOW TO MANAGE SIDE EFFECTS

Constipation

Try to eat more high-fibre foods such as fresh fruit, vegetables, cereals, and drink plenty of water. Try doing exercise regularly (going for a daily walk or run). If this does not help, inform your doctor for receiving alternate treatments for constipation.

Diarrhea

Drink lots of fluids, such as water to keep yourself hydrated. Try to avoid taking any medicine on your own to treat diarrhoea and consult your doctor if the symptom gets worse.

Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Consult your doctor if your dizziness worsens.

Headache

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Consult your doctor if your headache worsens.

Mouth Ulcers

Avoid eating spicy foods. Drink plenty of water. Apply a pain-relieving gel on the affected areas of the mouth if required. Consult your doctor if the symptom did not improve.

Nausea And Vomiting

Stick to simple meals. Avoid eating oil rich or spicy foods. If your nausea worsens, consult your doctor for advice.

Skin Rash Or Itching

Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. Consult your doctor if your skin rash worsens.

WARNING & PRECAUTIONS

PREGNANCY

Contraindicated

RITUXIREL 500MG INJECTION is generally not recommended for use in pregnant women. However, consult your doctor before receiving it. Women of childbearing potential must use a suitable contraceptive to avoid pregnancy while undergoing therapy with RITUXIREL 500MG INJECTION and until 12 months after stopping the therapy. If you accidentally became pregnant while receiving RITUXIREL 500MG INJECTION, inform your doctor immediately.

BREASTFEEDING

Contraindicated

RITUXIREL 500MG INJECTION is not recommended for use in breastfeeding women. Therefore, consult your doctor before receiving it.

DRIVING AND USING MACHINES

Use with Caution

Do not drive or operate any machines if your ability is affected by RITUXIREL 500MG INJECTION.

ALCOHOL

Consult your doctor

Avoid consumption of alcohol while receiving RITUXIREL 500MG INJECTION as it may make you feel drowsier.

ALLERGY

Contraindicated

Talk to your doctor before receiving RITUXIREL 500MG INJECTION if you are allergic to rituximab.

HEART DISEASE

Consult your doctor

RITUXIREL 500MG INJECTION is not recommended for use in patients with severe heart failure or uncontrollable heart problems. It should be used with caution in patients with other heart problems (such as angina, fast heart rate or heart failure). Therefore, consult your doctor before receiving it.

INTERACTIONS

A. Drug-Drug interactions:

Before receiving RITUXIREL 500MG INJECTION, inform your doctor if you are taking any of the following medicines such as:

• medicines used to treat high blood pressure (such as atenolol, propranolol, amlodipine, enalapril, olmesartan, losartan)
• medicines that can suppress immune functions (such as ciclosporin, tacrolimus)
• other anticancer medicines (such as Trastuzumab, Bevacizumab, Alemtuzumab, Cetuximab)

Overdosage:

RITUXIREL 500MG INJECTION will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your doctor if you experience any unusual symptoms.

SYNOPSIS

MORE INFORMATION

• Keep RITUXIREL 500MG INJECTION out of reach of children
• Store RITUXIREL 500MG INJECTION in a refrigerator (between 2-8°C)

FAQs ABOUT RITUXIREL 500MG INJECTION

Q: What RITUXIREL 500MG INJECTION is used for?

A: RITUXIREL 500MG INJECTION is used to treat blood cancer (leukaemia) and lymph cancer (lymphoma). It can also be used to treat various auto-immune disease conditions such as rheumatoid arthritis, granulomatosis with polyangiitis or microscopic polyangiitis (inflammation of blood vessels) and pemphigus vulgaris (severe skin blistering and peeling especially on the mouth, nose, throat, eyes and genitals).

Q: How RITUXIREL 500MG INJECTION works on my body?

A: RITUXIREL 500MG INJECTION is a monoclonal antibody. It destroys the immune cells (B-cells) that triggers cancer formation. It also reduces the production of certain chemicals within the body (such as rheumatoid factor, T-cells, cytokines) that causes inflammation, pain and swelling which helps in treating various autoimmune diseases.

Q: Can RITUXIREL 500MG INJECTION cure cancer?

A: The cure rate of cancer depends upon the severity of the disease. However, RITUXIREL 500MG INJECTION acts by preventing the abnormal growth and multiplication of cancer cells in the body, which may help in curing cancer completely.

Q: Can the use of RITUXIREL 500MG INJECTION cause hair loss?

A: Hair loss is one of the common side effects of receiving RITUXIREL 500MG INJECTION. If it bothers you, consult your doctor for advice.

Q: Can the use of RITUXIREL 500MG INJECTION cause mouth ulcers?

A: Mouth ulcers are one of the common side effects of receiving RITUXIREL 500MG INJECTION. Avoid eating spicy foods. Drink plenty of water. Apply a pain-relieving gel on the affected areas of the mouth if required. Consult your doctor if the symptom did not improve.

Q: Can RITUXIREL 500MG INJECTION be used in children?

A: RITUXIREL 500MG INJECTION should be used in children and adolescents (aged below 18 years) only if prescribed by the physician. Therefore, consult your doctor for advice before receiving it.

Q: What precautions must be followed while receiving RITUXIREL 500MG INJECTION?

A: Before receiving RITUXIREL 500MG INJECTION inform your doctor if you have any heart problems (such as chest pain, heart attack, heart failure or abnormal heartbeat). You must also inform your doctor if you currently have or previously had hepatitis B infection or any other mild infections (including minor cough and cold) as a precaution. RITUXIREL 500MG INJECTION is not recommended for use in pregnant or breastfeeding women. Both men and women receiving RITUXIREL 500MG INJECTION must use a suitable contraceptive method to avoid pregnancy while undergoing therapy with RITUXIREL 500MG INJECTION.

Q: What happens if I stop receiving RITUXIREL 500MG INJECTION?

A: No. Do not stop receiving RITUXIREL 500MG INJECTION without consulting your doctor as it may make your symptoms reappear. Therefore, take RITUXIREL 500MG INJECTION as advised by your doctor for the stipulated duration.

Q: Can RITUXIREL 500MG INJECTION be used during pregnancy?

A: RITUXIREL 500MG INJECTION is generally not recommended for use in pregnant women. If you accidentally became pregnant while receiving RITUXIREL 500MG INJECTION, inform your doctor immediately.

Q: Can the use of RITUXIREL 500MG INJECTION make me feel tired?

A: Yes. RITUXIREL 500MG INJECTION may make you feel tired easily. This is because, it reduces the levels of red blood cells in your blood and may make you anaemic. Consult your doctor if you experience tiredness after receiving RITUXIREL 500MG INJECTION. Tiredness can also occur if you have any pre-existing disease conditions such as liver or kidney impairment while taking this medicine.

Q: Can I drive a car after receiving RITUXIREL 500MG INJECTION?

A: RITUXIREL 500MG INJECTION may make you feel tired or dizzy. Therefore, do not drive or operate any heavy tools or machines if your ability is affected by RITUXIREL 500MG INJECTION.

Q: How RITUXIREL 500MG INJECTION is administered?

A: RITUXIREL 500MG INJECTION will be given to you only by a doctor or a nurse into a vein (as an intravenous infusion).

Q: How to control nausea caused due to RITUXIREL 500MG INJECTION?

A: Generally, anticancer medicines are associated with uncontrollable nausea and vomiting. To avoid this, your doctor would prescribe a suitable medicine to control them along with RITUXIREL 500MG INJECTION. If not, consult your doctor for a suitable anti-emetic medicine. Do not self-treat nausea.

Q: What are the side effects of receiving RITUXIREL 500MG INJECTION?

A: The most common side effects of receiving this medicine are fever, chills, skin rashes with itching, shortness of breath and low blood pressure. Consult your doctor if any of these side effect worsens.

REFERENCES

1. KD. Tripathi. Chemotherapy of Neoplastic Diseases. Essentials of Medical Pharmacology. 7th Edition. Page – 872.

2. Nazma Hanif, Faiz Anwer. Rituximab. StatPearls. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed central. September 2022. [Accessed on 28th January 2023] https://www.ncbi.nlm.nih.gov/books/NBK564374/

3. Roche Products Ltd. MabThera 100 mg and 500 mg concentrate solution for infusion. Rituximab. Electronics Medicines Compendium. [Revised in January 2022]. [Accessed on 28th January 2023] https://www.medicines.org.uk/emc/files/pil.3801.pdf

4. Biogen and Genentech USA, Inc. RITUXAN® (rituximab) injection, for intravenous use. U.S. Food and Drug Administration. [Revised in December 2021]. [Accessed on 28th January 2023] https://www.gene.com/download/pdf/rituxan_prescribing.pdf

5. Biogen and Genentech USA, Inc. Rituxan. Rituximab. [Accessed on 28th January 2023] https://www.rituxan.com/

6. Central Drugs Standard Control Organization. Rituximab (finished formulation import). July 2000. [Accessed on 28th January 2023] https://cdscoonline.gov.in/CDSCO/Drugs

USEFUL DIAGNOSTIC TESTS

• Complete Blood Count
• Peripheral Smear Examination
• Rheumatoid Factor-Agglutination
• Rheumatoid Factor-Turbidometry
• Rheumatoid Factor IgG Antibody

AUTHOR DETAILS

Written By Srilekha. R, B.Pharm
Last updated on 28 Jan 2023 | 04:59 PM(IST)