Sandoz launches generic Fosaprepitant in US, enhancing hospital offerings and strategically expanding injectables portfolio
Sep 02, 2020
Fosaprepitant is an antiemetic drug used in adults for the prevention of nausea and vomiting associated with certain chemotherapies1, which are amongst the most feared side effects for cancer patients starting chemotherapy2
Fosaprepitant launch complements Sandoz growing portfolio of injectable medicines and supports hospitals in offering cancer patients high-quality, more affordable treatment options
Sandoz is the global leader in generic oncology with a portfolio of 50+ medicines, including chemotherapy, targeted therapy, hormones and supportive care3
Princeton, New Jersey, September 2, 2020 — Sandoz Inc. today announced the immediate availability of antiemetic medicine Fosaprepitant for injection 150 mg in the US. Fosaprepitant is the generic of Emend®* (fosaprepitant dimeglumine) for injection and is used in adults in combination with other antiemetic drugs for the prevention of nausea and vomiting associated with certain chemotherapies, administered as IV infusion.
Nausea and vomiting are serious side effects of cancer chemotherapy that can cause significant negative impacts on patients’ quality of life and on their ability to tolerate and comply with therapy. These side effects are among the most distressing for patients.4
“Passion and commitment across Sandoz drive the successful launch of critical medicines like Fosaprepitant, which strategically aligns with growing our injectables portfolio and overall hospital offerings,” said Carol Lynch, President, Sandoz Inc. “We will continue to work hard to ensure cancer patients, including those treated in hospitals, have access to high-quality, affordable medicines that have the potential to improve their care.”
Fosaprepitant boosts Sandoz leading global generic oncology portfolio of more than 50 products, from chemotherapy, via hormones and supportive care, to targeted therapies.3 The Sandoz oncology offering is strongly complementary to the leading innovative presence of Novartis Oncology, with Sandoz oncology medicines reaching patients in nearly 100 countries.5
IMPORTANT SAFETY INFORMATION
Known hypersensitivity to any component of this drug.
Concurrent use with pimozide.
WARNINGS AND PRECAUTIONS
CYP3A4 Interactions: Fosaprepitant is a weak inhibitor of CYP3A4, and aprepitant, the active moiety, is a substrate, inhibitor and inducer of CYP3A4.
Use of fosaprepitant with other drugs that are CYP3A4 substrates, may result in increased plasma concentration of the concomitant drug.
Use of pimozide with fosaprepitant is contraindicated due to the risk of significantly increased plasma concentrations of pimozide, potentially resulting in prolongation of the QT interval, a known adverse reaction of pimozide.
Use of fosaprepitant with strong or moderate CYP3A4 inhibitors may increase plasma concentrations of aprepitant and result in an increased risk of adverse reactions related to fosaprepitant.
Use of fosaprepitant with strong CYP3A4 inducers may result in a reduction in aprepitant plasma concentrations and decreased efficacy of fosaprepitant.
Hypersensitivity Reactions (including anaphylaxis and anaphylactic shock): May occur during or soon after infusion. If symptoms occur, discontinue the drug. Do not reinitiate fosaprepitant if symptoms occur with previous use.
Infusion Site Reactions (including thrombophlebitis, necrosis and vasculitis): Majority of reactions reported in patients receiving vesicant chemotherapy. Avoid infusion into small veins or through a butterfly catheter. Discontinue infusion and administer treatment if a severe reaction develops.
Warfarin (a CYP2C9 substrate): Risk of decreased International Normalized Ratio (INR) of prothrombin time; monitor INR in 2-week period, particularly at 7 to 10 days, following initiation of fosaprepitant.
Hormonal Contraceptives: Efficacy of contraceptives may be reduced during and for 28 days following administration of fosaprepitant. Use effective alternative or back-up methods of contraception.
Most common adverse reactions in adults (≥2%) are: fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, pain in extremity, infusion-site reactions.
CYP3A4 Substrates: Increase exposure of pimozide (concurrent use is contraindicated), midazolam or other benzodiazepines metabolized via CYP3A4, dexamethasone, methylprednisolone, and chemotherapeutic agents that are metabolized by CYP3A4; decrease exposure of hormonal contraceptives during administration of and for 28 days after administration of the last dose of fosaprepitant.
CYP2C9 Substrates: Decrease warfarin exposure and prothrombin time (INR)
Moderate to Strong CYP3A4 Inhibitors: Significantly increased exposure of aprepitant may increase the risk of adverse reactions associated with fosaprepitant
Strong CYP3A4 Inducers: Substantially decreased exposure of aprepitant in patients chronically taking a strong CYP3A4 inducer may decrease the efficacy of fosaprepitant
Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use
Fosaprepitant for injection has not been studied for treatment of established nausea and vomiting
This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2019 sales of USD 9.7 billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.
2. Nurgali K, Jagoe RT, Abalo R. Editorial: Adverse Effects of Cancer Chemotherapy: Anything New to Improve Tolerance and Reduce Sequelae?. Front Pharmacol. 2018;9:245. Published 2018 Mar 22. doi:10.3389/fphar.2018.00245
3. IQVIA through November 2017, #1 position in generic oncology does not include Sandoz oncology biosimilars.
4. Rao KV, Faso A. Chemotherapy-induced nausea and vomiting: optimizing prevention and management. Am Health Drug Benefits. 2012;5(4):232-240.