REMS Updates for September and October 2021

REMS Updates for September and October 2021

Here you can find REMS Updates for September and October 2021

REMS Updates for September and October 2021

1. Sublocaderevised on September 30, 2021 to make editorial changes.

What is the purpose of the REMS?

The goal of the SUBLOCADE REMS is to mitigate the risk of serious harm or death that could result from intravenous self-administration by:

Ensuring healthcare settings and pharmacies are certified and only dispense SUBLOCADE directly to a healthcare provider for administration by a healthcare provider.

2. Yescarta and Tecartus modified on October 4, 2021 to make changes to the REMS materials to align with the labeling changes related to the approval of the Tecartus efficacy sBLA STN 125703/91 for the addition of a new indication for adult patients with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL) as follows:

• Grammatical edits to YESCARTA and TECARTUS REMS Document
• Add information on the adverse events of cytokine release syndrome (CRS) and neurological toxicities in patients with r/r B-cell precursor ALL to the YESCARTA and TECARTUS REMS Website and REMS Program Training
• Modify the YESCARTA and TECARTUS REMS Knowledge Assessment to improve question clarity and incorporate information for CRS and neurological toxicities with r/r B-cell precursor ALL

3. Isotretinoin iPledge modified October 8, 2021 to:

• Remove the Medication Guide as an element of the Risk Evaluation and Mitigation Strategy (REMS)
• Make changes to the REMS document and appended materials to align with labeling changes related to gender neutral patient risk categories
• Make changes to the REMS appended materials to reduce redundancy and streamline the content
• Make changes to the pharmacy operations to verify safe use conditions for the REMS risk management authorization
• Add an optional quick reference (QR) code for use by patients enrolled in the REMS
• Convert the REMS Document to the new, standardized format

4. Alosetronmodified October 18, 2021 to:

• Update the REMS Letter to Healthcare Providers to remove information related to program changes that were made in 2016, as that information is no longer relevant to prescribers becoming newly trained
• Make changes to the REMS call center hours
• Remove the option for prescribers to mail the Prescriber Completion of Training Form

5. Isotretinoin iPledge added ANDA 212333. 

What is the purpose of the REMS?

The goals of the isotretinoin risk evaluation and mitigation strategy are:

To prevent fetal exposure to isotretinoin

To inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions

6. Vigabatrin Shared System REMSadded ANDA’s 205109 and 213889.

What is the purpose of the REMS?

The goal of the Vigabatrin REMS Program is to mitigate the risk of vision loss associated with vigabatrin by:

• Ensuring that healthcare providers are educated about the risk of vision loss, the need to counsel patients about the risk, and the need for periodic visual monitoring.
• Ensuring that vigabatrin is only dispensed to patients with documentation that patients are informed about the risk of vision loss associated with vigabatrin and the need for periodic visual monitoring.

7. Mycophenolate Shared System REMSadded ANDA 20315.

What is the purpose of the REMS?

The goal of the Mycophenolate REMS is to mitigate the risk of embryofetal toxicity associated with use of mycophenolate during pregnancy by:

Educating healthcare providers on the following:

• The increased risks of first trimester pregnancy loss and congenital malformations associated with exposure to mycophenolate during pregnancy.
• The need to counsel females of reproductive potential on the importance of pregnancy prevention and planning when taking mycophenolate.
• The need to report pregnancies to the Mycophenolate Pregnancy Registry.

Informing females of reproductive potential who are prescribed mycophenolate about:

• The increased risks of pregnancy loss (miscarriage) and birth defects.
• The importance of pregnancy prevention and planning when taking mycophenolate.

8. Opioid Analgesic REMSadded the following:

• Buprenorphine transdermal, ANDA 210272
• Oxycodone hydrochloride tablets, ANDA 076758

What is the purpose of the REMS?

The goal of the Opioid Analgesic REMS is to educate prescribers and other healthcare providers (including pharmacists and nurses) on the treatment and monitoring of patients with pain. The education provided through the REMS program is based on the Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (“FDA Blueprint”).

Through better education, the healthcare team will have an improved understanding of how to manage pain and the role of opioid analgesics along with nonpharmacologic and non-opioid analgesics in pain management. The education will also provide information about the risks of opioids and use of other therapies which is intended to assist healthcare providers in reducing adverse outcomes of addiction, unintentional overdose, and death resulting from inappropriate prescribing, abuse, and misuse. The REMS will accomplish this goal by:

• Ensuring that training based on the FDA Blueprint is effective in educating prescribers and other healthcare providers involved in the treatment and monitoring of patients in pain (including pharmacists and nurses) about recommended pain management practices and appropriate use of opioid analgesics.
• Informing patients about their roles and responsibilities regarding their pain treatment plan, including the risks of opioid analgesics and how to use and store them safely, as outlined in the Medication Guides and Patient Counseling Guide for opioid analgesics.

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