Actemra

Question 1

Is there a pregnancy exposure registry for ACTEMRA?

Accepted Answer

Yes, there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ACTEMRA during pregnancy. Healthcare providers are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972.

Question 2

What is the risk of major birth defects and miscarriage associated with ACTEMRA?

Accepted Answer

The limited available data with ACTEMRA in pregnant women are not sufficient to determine whether there is a drug-associated risk for major birth defects and miscarriage. Monoclonal antibodies, such as tocilizumab, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. In animal reproduction studies, intravenous administration of tocilizumab to Cynomolgus monkeys during organogenesis caused abortion/embryo-fetal death at doses 1.25 times and higher than the maximum recommended human dose by the intravenous route of 8 mg per kg every 2 to 4 weeks. The literature in animals suggests that inhibition of IL-6 signaling may interfere with cervical ripening and dilatation and myometrial contractile activity leading to potential delays of parturition. Based on the animal data, there may be a potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Question 3

What are the clinical considerations for fetal/neonatal adverse reactions with ACTEMRA?

Accepted Answer

Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to ACTEMRA in utero.

Question 4

Is tocilizumab present in human milk?

Accepted Answer

No information is available on the presence of tocilizumab in human milk.

Question 5

What is the recommended course of action for lactating mothers who require ACTEMRA?

Accepted Answer

The lack of clinical data during lactation precludes clear determination of the risk of ACTEMRA to an infant during lactation; therefore the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ACTEMRA and the potential adverse effects on the breastfed child from tocilizumab or from the underlying maternal condition.

Question 6

What is ACTEMRA used for in pediatric patients?

Accepted Answer

ACTEMRA is indicated for the treatment of pediatric patients with active systemic or polyarticular juvenile idiopathic arthritis who are 2 years of age and older. It is also indicated for the treatment of severe or life-threatening cytokine release syndrome (CRS) in patients who are 2 years of age and older.

Question 7

Is ACTEMRA safe and effective for pediatric patients with conditions other than PJIA, SJIA, or CRS?

Accepted Answer

The safety and effectiveness of ACTEMRA in pediatric patients with conditions other than PJIA, SJIA, or CRS have not been established.

Question 8

What is the recommended dose of ACTEMRA for pediatric patients with SJIA?

Accepted Answer

For pediatric patients with systemic juvenile idiopathic arthritis (SJIA) who are 2 years of age and older, ACTEMRA is administered by intravenous use at a dose of 12 mg/kg every two weeks. Concurrent use of stable background treatment with corticosteroids, MTX, and/or non-steroidal anti-inflammatory drugs is permitted.

Question 9

What are the primary PK endpoints of ACTEMRA in pediatric patients with SJIA?

Accepted Answer

The primary PK endpoints (Cmax, Ctrough, and AUC2weeks) of ACTEMRA at steady-state in pediatric patients with SJIA who are under 2 years of age were within the ranges of these parameters observed in patients with SJIA aged 2 to 17 years.

Question 10

What are the safety considerations for pediatric patients receiving ACTEMRA for SJIA?

Accepted Answer

The safety and immunogenicity of ACTEMRA for patients with SJIA under 2 years of age was assessed descriptively. Serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and infectious AEs were reported by 27.3%, 36.4%, and 81.8% of patients. Hypersensitivity reactions were experienced by 6 patients (54.5%), with 3 of these patients experiencing serious hypersensitivity reactions and were withdrawn from the study. Three patients with hypersensitivity reactions (two with serious hypersensitivity reactions) developed treatment-induced anti-tocilizumab antibodies after the event. There were no cases of MAS based on the protocol-specified criteria, but 2 cases of suspected MAS based on Ravelli criteria.

Question 11

Is ACTEMRA indicated for pediatric patients below the age of 2?

Accepted Answer

The safety and effectiveness of ACTEMRA in pediatric patients below the age of 2 have not been established in PJIA, SJIA, or CRS.

Question 12

Is ACTEMRA indicated for subcutaneous use in pediatric patients?

Accepted Answer

Yes, ACTEMRA is indicated for subcutaneous use in pediatric patients with active systemic or polyarticular juvenile idiopathic arthritis who are 2 years of age and older.

Question 13

What is the geriatric use of ACTEMRA?

Accepted Answer

ACTEMRA is used for the treatment of rheumatoid arthritis in patients aged 65 years and older. The safety and efficacy of ACTEMRA in geriatric patients have been studied in several clinical trials.

Question 14

What is the incidence of serious infection among ACTEMRA treated geriatric patients?

Accepted Answer

The frequency of serious infection among ACTEMRA treated subjects aged 65 years and older was higher than those under the age of 65. This is because there is a higher incidence of infections in the elderly population in general. Therefore, caution should be used when treating the elderly with ACTEMRA.

Question 15

What are the considerations for geriatric patients receiving ACTEMRA?

Accepted Answer

Geriatric patients receiving ACTEMRA should be closely monitored for signs of infection, including tuberculosis, and other adverse events. The risks and benefits of treatment should be carefully considered in this population, and caution should be used when treating the elderly with ACTEMRA.

Patients less than 100 kg weight	162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response
Patients at or above 100 kg weight	162 mg administered subcutaneously every week

Recommended Intravenous PJIA Dosage Every 4 Weeks
Patients less than 30 kg weight	10 mg per kg
Patients at or above 30 kg weight	8 mg per kg

Recommended Subcutaneous PJIA Dosage
Patients less than 30 kg weight	162 mg once every three weeks
Patients at or above 30 kg weight	162 mg once every two weeks

Recommended Intravenous SJIA Dosage Every 2 Weeks
Patients less than 30 kg weight	12 mg per kg
Patients at or above 30 kg weight	8 mg per kg

Recommended Subcutaneous SJIA Dosage
Patients less than 30 kg weight	162 mg every two weeks
Patients at or above 30 kg weight	162 mg every week

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