INTRODUCTION ABOUT ACTEMRA 400MG INJECTION

ACTEMRA 400MG INJECTION contains Tocilizumab which belongs to the group of medicines called interleukin-6 (IL-6) receptor inhibitors. It is used to manage adults with moderate to severely active rheumatoid arthritis (an inflammatory disease affecting the joints).

It is also used in children aged 2 years and above to manage active systemic juvenile idiopathic arthritis and polyarticular juvenile idiopathic arthritis (inflammatory disease that causes pain and swelling in one or more joints).

ACTEMRA 400MG INJECTION is also used to manage adults and children aged 2 years and over with severe cytokine release syndrome (a side-effect in patients managed with chimeric antigen receptor (CAR) T-cell therapies used to manage certain types of cancer) and to manage adults with coronavirus disease 2019 (COVID-19), receiving systemic corticosteroids and requiring supplemental oxygen or mechanical ventilation.

ACTEMRA 400MG INJECTION is not recommended in patients with active, severe infection, active liver disease or liver impairment. It should be used with caution in patients with tuberculosis, mild to moderate kidney disease, intestinal ulcers or diverticulitis, cancer. Consult your doctor before receiving it.

ACTEMRA 400MG INJECTION is not recommended for use in pregnant women, breastfeeding mothers and in children under 2 years of age. Consult your doctor before receiving it.

The most common side effects of receiving ACTEMRA 400MG INJECTION include upper respiratory tract infections with typical symptoms such as cough, blocked nose, runny nose, sore throat and headache. Contact your doctor if any of the symptoms worsen.

USES OF ACTEMRA 400MG INJECTION

To manage:

moderate to severe active rheumatoid arthritis in adults
systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis in children
cytokine release syndrome in adults and children
coronavirus disease 2019 (COVID-19) in adults

HOW ACTEMRA 400MG INJECTION WORKS

ACTEMRA 400MG INJECTION works by blocking the activity of a specific protein (cytokine) called interleukin 6, which is involved in inflammatory processes of the body and blocking it can reduce the pain and swelling in your joints.

DIRECTIONS FOR USE

ACTEMRA 400MG INJECTION will be given to you only by a doctor or a nurse as an injection into a vein as intravenous infusion. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition. Do not stop using this medicine unless your doctor tells you to do so.

SIDE EFFECTS OF ACTEMRA 400MG INJECTION

COMMON

upper respiratory tract infections (symptoms such as cough, blocked nose, runny nose, sore throat and headache)
lung infection (pneumonia)
shingles (herpes zoster)
cold sores (oral herpes simplex), blisters
skin infection (cellulitis) with or without fever and chills
allergic reactions include rash and itching, hives
eye infection (conjunctivitis)
dizziness, headache
nausea, stomach pain, diarrhoea
mouth ulceration
fluid buildup in the lower legs, increase in weight

UNCOMMON

diverticulitis (fever, nausea, diarrhoea, constipation, stomach pain)
red swollen areas in the mouth
stomach ulcer
kidney stones
underactive thyroid

RARE

stevens-johnson syndrome (skin rash, which may lead to severe blistering and peeling of the skin)
fatal allergic reactions (Anaphylaxis)

Stop receiving ACTEMRA 400MG INJECTION and contact your doctor immediately if you experience any of the following side effects:

allergic reactions such as rash, itching, hives, swelling of the lips, tongue or face causing difficulty with breathing, chest tightness, wheezing, severe dizziness or light-headedness
signs of serious infections (fever and chills, mouth or skin blisters, stomachache) or feeling unwell
signs and symptoms of liver toxicity such as fatigue, weakness, nausea and vomiting, lack of appetite, yellowing of your skin or the whites of your eyes (jaundice), abdominal swelling and pain on the right side of your stomach-area, light colored stools, confusion and dark tea-colored urine.
symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever)
symptoms of perforation of the stomach or intestines such as fever, stomach pain, change in your bowel habits

HOW TO MANAGE SIDE EFFECTS

Nausea:

Try to receive this medicine with or just after a meal or a snack. Stick to simple meals. Avoid eating oily rich or spicy food. Contact your doctor if your nausea did not improve.

Stomach pain:

Try to have smaller meals but take them frequently. Keep a heating pad on your stomach. Do not self-manage and contact your doctor if your stomach pain did not improve.

Headache:

Rest and relax. Drink plenty of fluids such as water or ORS (Oral Rehydrating Solution) and apply a pain-relieving balm on the head if necessary. Contact your doctor if your headache did not improve.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any machines while you are feeling dizzy. Contact your doctor if your dizziness did not improve.

Skin rash:

Avoid hot baths because hot water can irritate your skin further. Do not scratch the affected area. Use sunscreen and wear protective clothing while going outside. Use unscented moisturizers to soothe and hydrate the affected area. Contact your doctor if your rashes worsen.

Diarrhoea:

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Do not take any medicine on your own for managing diarrhoea. Contact your doctor if your diarrhoea did not improve.

WARNING & PRECAUTIONS

PREGNANCY

ACTEMRA 400MG INJECTION is not recommended for use in pregnant women unless clearly necessary. Women of childbearing potential must use effective contraception during and up to 3 months after> management. Contact your doctor before receiving ACTEMRA 400MG INJECTION.

BREASTFEEDING

ACTEMRA 400MG INJECTION is not recommended for use in breastfeeding mothers as it is not known if it is excreted in the breastmilk. Leave a gap of at least 3 months after your last management before starting breast-feeding. Consult your doctor before receiving ACTEMRA 400MG INJECTION.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you feel dizzy after receiving ACTEMRA 400MG INJECTION.

KIDNEY

ACTEMRA 400MG INJECTION should be used with caution in patients with mild to moderate kidney disease with no dose adjustment. There is no information available on the use of this medicine in severe kidney disease. Consult your doctor before receiving ACTEMRA 400MG INJECTION.

LIVER

ACTEMRA 400MG INJECTION is not recommended in patients with active liver disease or liver impairment. Consult your doctor before receiving ACTEMRA 400MG INJECTION.

ALLERGY

Do not receive ACTEMRA 400MG INJECTION if you are allergic to Tocilizumab or any of the other ingredients of this medicine.

LUNGS

Do not receive ACTEMRA 400MG INJECTION if you are allergic to Tocilizumab or any of the other ingredients of this medicine.

HEART DISEASE

ACTEMRA 400MG INJECTION should be used with caution in patients with risk of heart disease (such as high blood pressure and high cholesterol level). Consult your doctor before receiving ACTEMRA 400MG INJECTION.

OTHERS

ACTEMRA 400MG INJECTION is not recommended for use if you:

have an active, severe infection

Before receiving ACTEMRA 400MG INJECTION, inform your doctor if you:

have any kind of infection, short- or long-term or if you often get infections
have had intestinal ulcers or diverticulitis
have recently been vaccinated (either adult or child) or is planning a vaccination
have cancer
have persistent headache
had a history of macrophage activation syndrome (activation and uncontrolled proliferation of specific blood cells) particularly in children
have multiple sclerosis and chronic inflammatory demyelinating polyneuropathy
have diabetes (high blood sugar)
have HIV or a weak immune system
are planning to have a surgery
have or ever had hepatitis B

Use in paediatrics:

ACTEMRA 400MG INJECTION is not recommended for use in children under 2 years of age. Consult your doctor before receiving ACTEMRA 400MG INJECTION.

Use in geriatrics:

ACTEMRA 400MG INJECTION should be used with caution in the elderly patients above 65 years of age. Consult your doctor before receiving ACTEMRA 400MG INJECTION.

INTERACTIONS

A. Drug-Drug interactions:

Before receiving ACTEMRA 400MG INJECTION, inform your doctor if you are taking any of the following medicines:

dexamethasone, methylprednisolone (used to reduce inflammation)
warfarin, phenprocoumon (used to thin the blood)
cyclosporine (used to manage graft rejection following an organ transplant surgery)
theophylline (used to manage asthma)
simvastatin, atorvastatin (used to manage high cholesterol levels in the body)
benzodiazepines Ex. temazepam (used to manage anxiety)
phenytoin (used to manage fits or seizures)
calcium channel blockers Ex. amlodipine (used to manage high blood pressure or hypertension)
medicines used to manage arthritis Ex. rituximab, trastuzumab
live vaccines Ex. rota virus vaccine, smallpox vaccine (used to manage infections)
oral contraceptives (medicines used to manage pregnancy) Ex. levonorgestrel
omeprazole (used to manage indigestion and heartburn)
dextromethorphan (used to manage dry cough)

Overdosage:

ACTEMRA 400MG INJECTION will be given to you only by a doctor or nurse in a hospital and so it is unlikely to receive an overdose. However, if you experience any unusual symptoms, contact your doctor immediately.

SYNOPSIS

Drug	:	Tocilizumab
Pharmacological Category	:	Interleukin-6 (IL-6) receptor inhibitors
Therapeutic Indication	:	Rheumatoid arthritis, Systemic juvenile idiopathic arthritis, Polyarticular juvenile idiopathic arthritis, Cytokine release syndrome, Coronavirus disease 2019 (COVID-19)
Dosage Forms	:	Injection

MORE INFORMATION

Keep ACTEMRA 400MG INJECTION out of reach from children
Store ACTEMRA 400MG INJECTION in a refrigerator (2°C - 8°C)

FAQs ABOUT ACTEMRA 400MG INJECTION

How often do you take ACTEMRA 400MG INJECTION?

ACTEMRA 400MG INJECTION will be given to you or to your child as an injection into a vein as an intravenous infusion once every 2 weeks or 4 weeks. Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition.

Does ACTEMRA 400MG INJECTION cause dizziness?

Yes, ACTEMRA 400MG INJECTION may cause dizziness. Try to rest and relax. Get enough sleep. Avoid driving or operating any machines while you are feeling dizzy. Contact your doctor if your dizziness did not improve.

Is ACTEMRA 400MG INJECTION safe for use in pregnant women?

ACTEMRA 400MG INJECTION is not recommended for use in pregnant women unless clearly necessary. Women of childbearing potential must use effective contraception during and up to 3 months after management. Contact your doctor before receiving ACTEMRA 400MG INJECTION.

Who should not receive ACTEMRA 400MG INJECTION?

ACTEMRA 400MG INJECTION is not recommended for use in pregnant, breastfeeding mothers with, allergic history to tocilizumab, active, severe infection, active liver disease or liver impairment and in children under 2 years of age. Consult your doctor before receiving ACTEMRA 400MG INJECTION.

What happens when you forget to receive ACTEMRA 400MG INJECTION?

ACTEMRA 400MG INJECTION will be given to you by a doctor or a nurse. It’s unlikely for you to miss the dose. However, if you are worried, talk to your doctor or nurse.

Is ACTEMRA 400MG INJECTION safe for use in children?

ACTEMRA 400MG INJECTION should be used with caution for the management of polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, cytokine release syndrome in children aged 2 years and above. Consult your doctor before receiving ACTEMRA 400MG INJECTION.

REFERENCES

1. Bertram G. Katzung. NSAIDs, Antirheumatic Drugs, Nonopioid Analgesics, & Drugs used in Gout. Basic and Clinical Pharmacology. 14th edition. 2018. Page – 653.

2. Graeme Jones and Changhai Ding. Tocilizumab: A Review of Its Safety and Efficacy in Rheumatoid Arthritis. NIH National Library of Medicine, National Center for Biotechnology Information. PubMed Central. December 2010. [Accessed on 22nd June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3018893/

3. Charles V. Preuss, Fatima Anjum. Tocilizumab. NIH National Library of Medicine, National Center for Biotechnology Information. StatPearls. [Revised in March 2022] [Accessed on 22nd June 2022] https://www.ncbi.nlm.nih.gov/books/NBK570644/

4. Roche Products Ltd. Electronic Medicines Compendium (EMC). Tocilizumab [Revised in January 2022] [Accessed on 22nd June 2022] https://www.medicines.org.uk/emc/files/pil.6673.pdf

5. Tocilizumab Injection. DailyMed: National Library of Medicine: National Institute of Health. [Revised in June 2022] [Accessed on 22nd June 2022] https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13&type=display#section-7

6. Actemra IV Injection (Tocilizumab). Ciplamed. [Revised in February 2021] [Accessed on 22nd June 2022] https://ciplamed.com/content/actemra-iv-injection

USEFUL DIAGNOSTIC TESTS

Complete blood picture (CBC)
Liver function test (LFT)
C-reactive protein (CRP)
Erythrocyte sedimentation rate (ESR)
Anti-cyclic citrullinated peptide (anti-CCP)
Antinuclear antibodies (ANAs)
Rheumatoid factor (RF)

AUTHOR DETAILS

Written By Dr. N. Sai Swaroop - Pharm.D

Last updated on 11 Jan 2023 | 06:02 PM(IST)

Actemra 400mg Injection 1'S

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