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Actemra
Roche Bangladesh Pharmaceutical
Generic: Tocilizumab
Safety Advices
বাংলা
English
SAFE
Consuming alcohol with Actemra does not cause any harmful side effects.
CONSULT YOUR DOCTOR
Actemra may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
SAFE IF PRESCRIBED
Actemra is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.
UNSAFE
Actemra may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur.
CAUTION
Actemra should be used with caution in patients with kidney disease. Dose adjustment of Actemra may be needed. Please consult your doctor.
Limited information is available on the use of Actemra in patients with moderate to severe kidney disease. No dose adjustment is required in patients with mild kidney disease.
CAUTION
Actemra should be used with caution in patients with liver disease. Dose adjustment of Actemra may be needed. Please consult your doctor.
Use of Actemra is not recommended in patients with active liver disease.
Medicine Overview of Actemra 162mg/0.9mlVial SC Injection
Introduction
Actemra is a medicine used to treat various inflammatory conditions of the joints (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis), skin (psoriasis), and bowel (ulcerative colitis, Crohn’s disease). It reduces swelling in these conditions by blocking TNF alpha. Actemra is given by a healthcare professional and should not be self-administered. You should use it regularly and at the same time each day to get the maximum benefit from it. Continue using it as recommended by your doctor and complete the dose even if you feel better. The most common side effects seen with this medicine include headache, high blood pressure, upper...
... Show moreUses of Actemra
- Ankylosing spondylitis
- Rheumatoid arthritis
- Psoriasis
- Ulcerative Colitis
- Crohn’s disease
Side effects of Actemra
Common
- Headache
- High blood pressure
- Upper respiratory tract infection
- Increased liver enzymes
- Nasopharyngitis (inflammation of the throat and nasal passages)
How to use Actemra
Your doctor or nurse will give you this medicine. Kindly do not self administer.
How Actemra works
Actemra blocks the action of certain chemical messengers that are responsible for inflammation, swelling and redness associated with certain joint diseases.
What if you forget to take Actemra?
If you miss a dose of Actemra, please consult your doctor.
Quick Tips
- ACTEMRA 400 MG INJECTION is given as a drip (intravenous infusion) or as an injection directly into a vein.
- You may be asked for regular blood tests to check blood counts, cholesterol level and liver functioning during the treatment.
- 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.
Brief Description
Indication
Juvenile idiopathic arthritis, Rheumatoid Arthritis (RA)
Administration
IV Preparation Withdraw a volume of 0.9% NaCl from bag/bottle equal to volume of the solution required for the patient's dose Adults and children weighing >30 kg: Dilute to 100 mL in 0.9% NaCl Children <30 kg: Dilute to 50 mL in 0.9% NaCl Slowly add dose to infusion bag or bottle and gently invert to mix (prevent foaming) IV Administration Administer as single IV infusion over 1 hr Do NOT administer as bolus or push Do not infuse with any other drugs as no compatibility studies have been conducted SC Preparation Remove prefilled SC syringe from refrigerator 30 minutes...
... Show moreAdult Dose
Parenteral
Adult:
Rheumatoid Arthritis
Indicated for adults with moderate-to-severe active rheumatoid arthritis with inadequate response to 1 or more DMARDs as an IV infusion or SC injection
May use alone or in combination with methotrexate or other DMARDs
IV infusion
4 mg/kg IV q4wk initially; may increase to 8 mg/kg q4wk based on clinical response
Not to exceed 800 mg/dose q4wk
SC injection
Weight 100 kg: 162 mg SC every week
Hepatic impairment
Not recommended with active hepatic disease or hepatic impairment
Child Dose
Systemic Juvenile Idiopathic Arthritis (SJIA, Still's Disease)
2 years or older (30 kg): 8 mg/kg IV q2weeks
May be administered as monotherapy or with methotrexate
Polyarticular Juvenile Idiopathic Arthritis (PJIA)
2 years or older (30 kg or more): 8 mg/kg IV q4weeks
May be administered as monotherapy or with methotrexate
Renal Dose
Renal impairment
Mild: No dosage adjustment required
Moderate-to-severe: Has not been studied
Contraindication
Hypersensitivity
Mode of Action
Interleukin-6 receptor antagonist; changes in clinical trials observed include decreased C-reactive protein level to within normal range, decreased values in other pharmacodynamic parameters (eg, rheumatoid factor, erythrocyte sedimentation rate, amyloid A), and increased hemoglobin value
Precaution
Serious infections leading to hospitalization or death (ie, tuberculosis; bacterial, invasive fungal, viral, or other opportunistic infections) have occurred with use
Stop therapy if serious infection occurs; can restart if infection is controlled
Test for latent tuberculosis before initiating; if positive, initiate tuberculosis therapy before starting tocilizumab
Continue to monitor all patients for active tuberculosis during therapy
Lactation: unknown whether distributed in breast milk, do not breast feed
Side Effect
>10%
SC injection site reactions (7.1-10.1%)
1-10%
Upper respiratory tract infections,Nasopharyngitis,Headache,Hypertension,Increased ALT,Infusion related skin reactions (eg, rash, pruritus, urticaria),Dose related adverse reactions including decreased neutrophil count <1000/cu.mm, decreased platelets <100,000/cu.mm,Lipid elevations,Mouth ulcerations,Gastritis,Upper abdominal pain
Interaction
Interactions with Other Medications and Other Forms of Interaction: Population pharmacokinetic analyses did not detect any effect of MTX, nonsteroidal anti-inflammatory drugs or corticosteroids on tocilizumab clearance. Tocilizumab has not been studied in combination with other biological DMARDs. The expression of hepatic CYP450 enzymes is suppressed by cytokines, eg, IL-6, that stimulate chronic inflammation. Thus, CYP450 expression may be reversed when potent cytokine inhibitory therapy, eg, tocilizumab is introduced. In vitro studies with cultured human hepatocytes demonstrated that IL-6 caused a reduction in CYP1A2, CYP2C9, CYP2C19, and CYP3A4 enzyme expression. Tocilizumab normalizes expression of these enzymes. The effect of tocilizumab...
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