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Actemra 400 mg / 20 mL ( Tocilizumab ) Vial for IV infusion

ContainsTocilizumab

Description

Actemra 400 mg Injection belongs to a group of medicines called anti-rheumatic agents. It is used for the treatment of mild to moderate rheumatic arthritis (RA) and giant cell arteritis (GCA) in adults. It is also used for the treatment of Polyarticular juvenile idiopathic arthritis (PJIA), systemic juvenile idiopathic arthritis, and cytokine release syndrome in children aged two years and above. It may be used alone or in a combination with other medicines for the treatment of the above-mentioned diseases.

Side effects

Major & minor side effects for Actemra 400 mg Injection

Mild fever and chills
High blood pressure
Skin rash and itching
Headache
Flu like symptoms
Sore throat
Nausea and Vomiting
Stomach pain
Constipation
Mouth blisters
Joint pain
Difficult and painful breathing
Severe light-headedness
Severe skin rash and hives
Black or tarry stools
Bloody or coffee colored vomit
Blurred vision
Bloody or cloudy urine
Change in heart rate
Unusual bleeding or bruising
Loss of appetite
Injection site bruising and red coloration
Loss of consciousness
Skin blistering
Diarrhea

Uses of Actemra 400 mg Injection

What is it prescribed for?

Rheumatoid Arthritis
This medicine is indicated for the treatment of rheumatoid arthritis, an immune disorder characterized by pain and swelling of joints. It is normally used when other disease-modifying anti-rheumatoid medications are not effective.
Giant cell arteritis
This medicine is indicated for the treatment of giant cell arteritis, a condition where blood vessels, particularly in the head and scalp area, become swollen.
Polyarticular juvenile idiopathic arthritis
This medicine is indicated for the treatment of polyarticular juvenile idiopathic arthritis, an arthritic condition in children characterized by swollen and painful joints. It should only be used in children aged 2 years or above.
Systemic juvenile idiopathic arthritis
This medicine is indicated for the treatment of systemic juvenile idiopathic arthritis, an inflammatory condition causing fever, pain, swelling, and developmental abnormalities of different parts of the body in children aged 2 years and above.
Cytokine release syndrome
This medicine is used for the treatment of cytokine release syndrome, a severe and life-threatening reaction that usually develops after receiving certain immunotherapy medications via infusion.

Concerns

Commonly asked questions

How long does it take for this medicine to take effect?

The amount of time required for this medicine to show its action is not clinically established.
How long do the effects of this medicine last?

The amount of time for which this medicine remains active in the body is not clinically established.
Is it safe to consume alcohol while taking this medicine?

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
Is this a habit forming medicine?

No habit-forming tendencies were reported.
Can this medicine be taken during pregnancy?

This medicine is not recommended for use in pregnant women unless absolutely necessary. All the potential benefits and risks associated with use should be carefully evaluated. Your doctor may prescribe an alternative medicine based on your clinical condition.
Can this medicine be taken while breast-feeding?

This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before using/receiving this medicine. Your doctor may advise you to discontinue the drug or to discontinue breastfeeding based on your clinical condition.

When not to use?

Allergy

This medicine is not recommended for use in patients with a known allergy to tocilizumab or any other inactive ingredients present along in the formulation. It is also not recommended for use if you have a history of allergy to any other recombinant human or humanized antibodies or proteins that are of hamster origin.

Active severe infection

This medicine is not recommended for use in patients suffering from an active severe infection due to the increased risk of worsening of the patient's condition.

Warnings

Warnings for special population

Pregnancy

This medicine is not recommended for use in pregnant women unless absolutely necessary. All the potential benefits and risks associated with use should be carefully evaluated. Your doctor may prescribe an alternative medicine based on your clinical condition.

Breast-feeding

This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before using/receiving this medicine. Your doctor may advise you to discontinue the drug or to discontinue breastfeeding based on your clinical condition.

General warnings

Low blood cell counts

This medicine is not recommended for use in patients with lower values of absolute neutrophil count and platelet counts. Monitoring of these levels is necessary every 4-8 weeks while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition of the patient.

Elevated liver enzymes

This medicine is not recommended for use in patients with ALT and AST levels more than 1.5 times of the upper limit of normal. Monitoring of these levels is necessary every 4-8 weeks while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition of the patient.

Lipid abnormalities

This medicine is not recommended for use in patients with higher levels of triglycerides or cholesterol. Monitoring of these levels is necessary every 4-8 weeks while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition of the patient.

Immune suppression

Usage of this medicine weakens your immune system, thereby increasing the chances of opportunistic infections. Suitable preventive measures should be adopted to avoid such infections.

Vaccinations

Vaccinations with live or attenuated strains of micro-organisms should be avoided while taking this medicine due to the increased risk of worsening of the patient’s condition. Similarly, treatment with this medicine should not be initiated if the patient has been vaccinated recently.

Other medicines

Actemra 400 mg Injection may interact with many other medicines and may cause severe adverse effects. Hence, it is advised that you inform the doctor about all your current medici

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