Actemra 80mg/4ml IV Infusion

✔️ Uses of Actemra 80mg/4ml IV Infusion

Treatment of Rheumatoid arthritis, Ankylosing spondylitis, and giant cell arteritis.

✔️ How does Actemra 80mg/4ml IV Infusion work?

Actemra 80mg/4ml IV Infusion 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.

✔️ Side Effects of Actemra 80mg/4ml IV Infusion

• Runny nose
• Sinus pain
• Sore throat
• Increased blood pressure
• Pain and swelling at the injection site
• Headache

✔️ Quick Suggestions:

• Actemra 80mg/4ml IV Infusion is given as a drip (intravenous infusion) or as an injection directly into a vein.
• During the treatment, you may be asked for regular blood tests to check blood counts, cholesterol levels,s, and liver function.
• It might make you feel dizzy. If this happens, avoid driving or operating on machinery.
• It makes it hard to fight with an infection. Inform your doctor if you notice fever, cough, or stomach pain.
• Inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding.
• Do not stop taking medicine without talking to your doctor first.

✔️ Indication of Actemra 80mg/4ml IV Infusion

Actemra 80mg/4ml IV Infusion 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).

✔️ Pharmacology

Tocilizumab is a humanized monoclonal antibody that targets and inhibits the interleukin-6 (IL-6) receptor, which is part of the immunoglobulin IgG1K subclass. By binding to both soluble and membrane-bound IL-6 receptors, Tocilizumab effectively blocks IL-6-mediated signaling. IL-6 is a key pro-inflammatory cytokine produced by various cells, including T-cells, B-cells, monocytes, and fibroblasts. It plays a significant role in immune system functions like T-cell activation, antibody production, liver protein synthesis, and blood cell formation. Additionally, IL-6 is involved in local inflammatory processes in the joints, contributing to conditions like rheumatoid arthritis.

✔️ Dosage & Administration of Actemra 80mg/4ml IV Infusion

Intravenous (IV) Preparation:

Subcutaneous (SC) Preparation and Administration:

Dosage Recommendations:

Adult Dose:

Rheumatoid Arthritis:

• IV Infusion:
  • Start with 4 mg/kg every 4 weeks.
  • May increase to 8 mg/kg every 4 weeks based on clinical response.
  • Maximum dose: 800 mg per infusion.
• SC Injection:
  • Weight < 100 kg: 162 mg SC every other week, increasing to every week based on clinical response.
  • Weight > 100 kg: 162 mg SC every week.

Hepatic Impairment:

• Not recommended in patients with active hepatic disease or hepatic impairment.

Child Dose:

Systemic Juvenile Idiopathic Arthritis (SJIA):

• < 2 years: Safety and efficacy not established.
• > 2 years:
  • Weight < 30 kg: 12 mg/kg IV every 2 weeks.
  • Weight > 30 kg: 8 mg/kg IV every 2 weeks.
  • Can be administered as monotherapy or with methotrexate.

Polyarticular Juvenile Idiopathic Arthritis (PJIA):

• < 2 years: Safety and efficacy not established.
• > 2 years:
  • Weight < 30 kg: 10 mg/kg IV every 4 weeks.
  • Weight > 30 kg: 8 mg/kg IV every 4 weeks.
  • Can be administered as monotherapy or with methotrexate.

Renal Dose:

• Mild Renal Impairment: No dosage adjustment is required.
• Moderate-to-severe renal Impairment: Has not been studied.

✔️ Drug Interactions with Tocilizumab

Drug-Drug Interactions:

• Immunosuppressants: Tocilizumab may interact with other immunosuppressants such as certolizumab, golimumab, infliximab, adalimumab, and rituximab.
• Rheumatoid Arthritis Medications: Be cautious when combining Tocilizumab with other rheumatoid arthritis medications like Abatacept, etanercept, and Anakinra.
• Blood Thinners: It can interact with blood thinners such as warfarin, potentially affecting their efficacy.
• Cholesterol-Lowering Drugs: Tocilizumab may interact with cholesterol-lowering medications like atorvastatin, lovastatin, and simvastatin.
• Acid-Reducing Medications: Interaction with drugs used to treat acidity, such as omeprazole, may occur.
• Cough Suppressants: Tocilizumab can interact with cough suppressants like dextromethorphan.
• Birth Control Pills: Tocilizumab may reduce the effectiveness of oral contraceptives.

Drug-Food Interaction:

• Alcohol: Consuming alcohol while on Tocilizumab can increase dizziness and raise the risk of stomach ulcers and bleeding.

Drug-Disease Interactions:

• Caution Required: Use Tocilizumab cautiously if you have liver, heart, or kidney diseases, stomach or intestinal ulcers, multiple sclerosis, low blood cell count, diabetes, a weakened immune system (e.g., HIV), hepatitis B, cancer, or active infections.

✔️ Contraindications

Tocilizumab is contraindicated in patients with known hypersensitivity to Tocilizumab.

✔️ Pregnancy & Lactation

Based on animal data, may cause fetal harm. In case of COVID-19, Tocilizumab should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus. Discontinue drug or nursing taking into consideration importance of drug to mother. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

✔️ Drug Warnings for Tocilizumab

• Pre-Existing Conditions: Before starting Tocilizumab, inform your doctor if you have any liver, heart, or kidney diseases, stomach or intestinal ulcers (such as diverticulitis), multiple sclerosis, low blood cell count, diabetes, a weakened immune system (e.g., HIV), hepatitis B, cancer, or any active infections.
• Infection Precautions: Avoid close contact with individuals who have contagious infections like chickenpox, measles, tuberculosis, or the flu. Practice good hygiene, including thorough handwashing, to prevent the spread of infection.
• Vaccinations: Do not receive live vaccines while being treated with Tocilizumab, as this could lead to serious complications.
• Alcohol and Driving: Tocilizumab may cause dizziness or drowsiness. Avoid alcohol, as it can exacerbate these effects and increase the risk of stomach bleeding or ulcers. Only drive if you feel alert and focused.
• Pediatric Use: Tocilizumab is not recommended for children under two years of age as its safety and efficacy in this age group have not been established.
• Storage: Store Tocilizumab at temperatures between 2°C and 8°C. Do not freeze the vial.

✔️ Storage:

• Keep Actemra 80mg/4ml IV Infusion out of reach from children
• Store Actemra 80mg/4ml IV Infusion in a refrigerator (2°C - 8°C)