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Actemra 80 mg Injection

Manufactured byRoche India
ContainsTocilizumab
Description
Actemra 80 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 80 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 80 mg Injection

What is it prescribed for?

  • Rheumatoid Arthritis
  • Giant cell arteritis
  • Polyarticular juvenile idiopathic arthritis
  • Systemic juvenile idiopathic arthritis
  • Cytokine release syndrome
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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.

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 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 80 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 medicines including any herbs and supplements before beginning treatment with this medicine.

Heart diseases

This medicine should be used with caution in patients who are suffering from heart diseases due to the increased risk of worsening of the patient's condition. You may require a dose adjustment and more frequent clinical monitoring to safely use this medicine. An alternative treatment option may be necessary in some cases based on the clinical condition of the patient.

Driving or operating machinery

Use of this medicine may cause blurred vision or dizziness in some patients. It is advised that you do not perform any activities such as driving a vehicle or operating machinery if you experience any of these symptoms during treatment with this medicine.

Intravenous administration

When used intravenously, this medicine should be infused over a duration of at least 60 minutes.

Missed Dose

Infusion: Since this medicine is usually administered by a qualified healthcare professional in the clinical/hospital setting, the likelihood of a missed dose is very low. Subcutaneous injection: Administer the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not double your dose to make up for the missed one.

Overdose

Infusion: Since this medicine is administered in the hospital setting by a qualified healthcare professional, the likelihood of an overdose is very low. However, emergency medical treatment will be initiated by the doctor if an overdose is suspected. Subcutaneous injection: Seek emergency medical treatment or contact the doctor in case of an overdose.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

Instructions

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
Interaction with Medicine

Live vaccines

Adalimumab

Amlodipine

Phenytoin

Theophylline

Cyclosporine

Warfarin

Atorvastatin

Disease interactions

Infections

This medicine should be used with extreme caution in patients with a history of recent infections and it is not recommended for use in case of active infections due to the increased risk of worsening of the patient’s condition. An alternative treatment option may be necessary in some cases based on the clinical condition of the patient.

Demyelinating disorders

This medicine is not recommended for use in patients with demyelinating disorders such as chronic inflammatory demyelinating polyneuropathy or multiple sclerosis due to the increased risk of worsening of the patient’s condition. You may require a dose adjustment and more frequent clinical monitoring to safely use this medicine. An alternative treatment may be necessary in some cases based on the clinical condition of the patient.

Gastrointestinal perforations

This medicine should be used with caution in patients with gastrointestinal perforations due to the increased risk of worsening of the patient’s condition. You may require a dose adjustment and more frequent clinical monitoring to safely use this medicine. An alternative treatment option may be necessary in some cases based on the clinical condition of the patient.

Liver impairment

This medicine should be used with caution in patients with liver diseases. Close monitoring of liver function tests is necessary 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.

Impaired kidney function

This medicine should be used with caution in patients with kidney diseases. Close monitoring of kidney function tests is necessary 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.
Food interactions
Information not available.
Lab interactions
Information not available.
Infusion: This medicine is usually administered in the clinical/hospital setting under the supervision of a qualified healthcare professional. Follow all the instructions given by your doctor. Inform the doctor if you have a known allergy to this medicine. Report all your current medicines as well as your medical conditions to the doctor before receiving this medicine. Subcutaneous injection: Follow all the instructions given by your doctor and administer this medicine exactly as advised. Do not administer in larger or smaller amounts than prescribed. Seek emergency medical treatment in case of any severe side effects. Ensure that the course of treatment is completed. Do not stop the use of this medicine without consulting your doctor.
Miscelleneous

Usage does not depend on food timings

To be taken as instructed by doctor

May cause sleepiness

How it works
This medicine works by reducing the effect of certain specific substances in the body that cause inflammation (pain, redness, swelling, stiffness, etc.) in arthritic conditions.
Legal Status

Approved

Approved

Approved

Approved

Classification

Category

Interleukin inhibitors

Schedule

Schedule G

[Internet]. Actemrahcp.com. 2018 [cited 17 August 2018]. Available from:

https://www.actemrahcp.com/ra/education-training.html

[Internet]. Accessdata.fda.gov. 2018 [cited 17 August 2018]. Available from:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s114lbl.pdf

[Internet]. Medicines.org.au. 2018 [cited 17 August 2018]. Available from:

http://www.medicines.org.au/files/rocactai.pdf

[Internet]. Dailymed.nlm.nih.gov. 2018 [cited 17 August 2018]. Available from:

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13

Tocilizumab (Actemra) [Internet]. Rheumatology.org. 2018 [cited 17 August 2018]. Available from:

https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Treatments/Tocilizumab-Actemra
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Information on this page was last updated on 24 Dec 2018

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