November 2024 Drug Safety Updates Part 4: Cancer Drugs: Ayvakit, Keytruda, Oxaliplatin, more
Ayvakit (avapritinib) tablets
Ayvakit treats metastatic stomach cancer, aggressive systemic mastocytosis (ASM), and mast cell leukemia (MCL). The label was updated to warn about drug interactions. Specifically, patients are warned that coadministration of AYVAKIT with ethinyl estradiol-containing contraceptives may increase the exposure of ethinyl estradiol, which may lead to ethinyl estradiol-associated adverse reactions. If an estrogen-containing contraceptive must be used, a formulation containing 20 mcg or less is recommended.
Because of the risk of fetal harm, males and females of reproductive potential are advised to use effective contraception during treatment with Ayvakit and for 6 weeks after the final dose.
Ayvakit was initially approved in 2020.
Ayvakit FDA Safety Label Change
Herzuma (trastuzumab-pkrb) and Ogivri (trastuzumab-dkst)
Breast cancer and stomach cancer (HER-2 positive) treatment Herzuma boxed warning now advises testing prior to and during treatment in order to evaluate cardiac function. Providers are advised to evaluate left ventricular ejection fraction (LVEF) prior to initiation of HERZUMA and at regular intervals during treatment.
Post-marketing reports including studies in published literature suggest that use of trastuzumab products during pregnancy resulted in cases of oligohydramnios (low level of amniotic fluid). In most reported cases, amniotic fluid index increased after trastuzumab was stopped.
Read the revised drug label for all of the changes.
Herzuma was initially approved in 2018 and is biosimilar (biological generic) to HERCEPTIN (trastuzumab).
Herzuma FDA Safety Label Change
Ogivri (trastuzumab-dkst) for injection, for intravenous use, also revised its boxed warning and other sections to advise testing for left ventricular ejection fraction prior to and during treatment. Also, the instruction was added to verify the pregnancy status of females of reproductive potential prior to the initiation of Ogivri.
Ogivri was initially approved in 2017 and is a biosimilar (biological generic) to HERCEPTIN (trastuzumab).
Ogivri FDA Safety Label Change
Keytruda (pembrolizumab) injection for I.V. use
Keytruda, a monoclonal antibody therapy used for multiple types of cancer, had a label update to provide clinical trials data from the Keynote-051 study of patients with advanced melanoma, lymphoma, and other tumor types.
In other news about Keytruda, Merck says testing of an under-the-skin (or subcutaneous) version of Keytruda in a Phase 3 trial shows it is comparable to the I.V. formulation.
https://finance.yahoo.com/news/under-skin-keytruda-comparable-infused-114700651.html
Keytruda was initially approved in 2014.
Keytruda FDA Safety Label Change
Lenvima (lenvatinib mesylate) capsules
Thyroid, advanced kidney liver and endometrial cancer drug Lenvima updated a list of adverse reactions that occurred in greater than or equal to 20% of patients receiving Lenvima plus Pembrolizumab. Hypothyroidism and hypertension are the top two adverse reactions on the list.
Lenvima was initially approved in 2015.
Lenvima FDA Safety Label Change
Lunsumio (mosunetuzumab-axgb) injection for intravenous use
Lymphoma (relapsed or refractory follicular lymphoma) monoclonal antibody drug Lunsumio updated its label with clinical trials information about life-threatening neurological toxicity, including " Immune Effector Cell-Associated Neurotoxicity Syndrome." Also, a new section warns about the risk of fatal or serious hemophagocytic lymphohistiocytosis (HLH). HLH is a potentially life-threatening, hyperinflammatory syndrome, which is a distinct condition from Cytokine Release Syndrome (CRS). Lunsumio has a boxed warning about the risk of CRS.
Lunsumio was initially approved in 2022.
Lunsumio FDA Safety Label Change
Oxaliplatin injection, for intravenous use
Oxaliplatin Injection is a platinum-based drug used in combination with fluorouracil and leucovorin to treat advanced colorectal cancer. Revised the boxed warning about hypersensitivity reactions. Serious and fatal hypersensitivity adverse reactions can occur within minutes of administration. Drug is contraindicated in patients with hypersensitivity reactions to oxaliplatin and other platinum-based drugs. Clinical trials results were updated. Please see the complete label for all the changes.
Oxaliplatin was initially approved in 2002.
Oxaliplatin FDA Safety Label Change
Scemblix (asciminib hydrochloride)
Leukemia drug Scemblix received a safety label update to support its expanded approval for treating adults with NEWLY DIAGNOSED cases of Philadelphia chromosome-positive chronic myelogenous leukemia, also known as CML, a type of cancer of the white blood cells.
CML occurs when a cell in the bone marrow undergoes a breakage of two chromosomes (chromosomes 9 and 22), which then fuse to form a characteristic abnormal chromosome, called the Philadelphia chromosome (named for the city in which it was first identified).
Extensive clinical trials data were added to the warnings and precautions section under myelosuppression, pancreatic toxicity, hypertension, and more. Among the 556 patients in three of the studies, 130 (23%) were 65 years of age and older and 31 (6%) were 75 years of age and older. Overall, no differences in safety or efficacy of SCEMBLIX were observed between patients 65 years of age and older compared to younger patients.
Scemblix was initially approved in 2021. The new approval was granted under "accelerated" status, and may be contingent upon additional clinical trial results. Check the label for all of the clinical trials additions.
More info on Scemblix’s new approval from Pharma Phorum:
https://pharmaphorum.com/news/novartis-gets-fda-okay-frontline-use-scemblix-cml
Scemblix FDA Safety Label Change
Vonjo (pacritinib citrate) capsules
Vonjo is used to treat primary or secondary myelofibrosis (a bone marrow blood cancer). The warnings and precautions and the patient information section were updated to inform of drug interactions. Strong and moderate CYP3A4 inhibitors taken concurrently will reduce the effectiveness of Vonjo.
Warnings are also added about interactions with other types of drugs, including hormonal contraceptives.
The side effect of low platelet counts was added to the "most common side effects" section of the patient information guide. It advises that your healthcare provider will do blood tests and an electrocardiogram (ECG) before starting treatment and as needed during treatment to check for side effects.
Vonjo was initially approved in 2022.
Vonjo FDA Safety Label Change
Check out these new FDA safety updates on GLP-1 diabetes and weight loss drugs. Includes ten meds for type 2 (like Mounjaro and Ozempic) and three weight loss drugs (like Wegovy and Zepbound) plus links to the safety label updates:
Did you miss November Part 3 Safety Update? Read it here:
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