CUMBERLAND PHARMACEUTICALS ACQUIRES SANCUSO® FROM KYOWA KIRIN NORTH AMERICA
SANCUSO is the first and only FDA-approved prescription patch for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment. The active drug in SANCUSO, granisetron, slowly dissolves in the thin layer of adhesive that sticks to the patient's skin and is released into their bloodstream over several days, working continuously to prevent chemotherapy-induced nausea and vomiting (CINV). It is applied 24 to 48 hours before receiving chemotherapy and can prevent CINV for up to five consecutive days. Alternative oral treatments must be taken several times (day and night) to deliver the same therapeutic doses.
"In 2020 there were nearly two million new cases of cancer in the
Under the terms of the agreement, Cumberland will acquire
"Since its launch in 2008, we have established SANCUSO as an important supportive therapeutic solution for oncology patients across the country," said
The Company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy ("DMD"), Systemic Sclerosis ("SSc"), and Aspirin-Exacerbated Respiratory Disease ("AERD").
More information can be found on the Company's website at www.cumberlandpharma.com.
Learn more about the Company at www.kyowakirin.com.
SANCUSO is the only skin patch approved by the
Learn more at www.sancuso.com.
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Please see SANCUSO Indication and Important Safety Information below
SANCUSO® (granisetron transdermal system) is indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to five5 consecutive days.
Important Safety Information
SANCUSO is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the transdermal system.
Warnings and Precautions:
Progressive Ileus and Gastric Distention: SANCUSO may mask a progressive ileus and/or gastric distention. This should be particularly considered before use of SANCUSO in patients who have had recent abdominal surgery. Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction.
Serotonin Syndrome: The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists. Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of SANCUSO and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue SANCUSO and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if SANCUSO is used concomitantly with other serotonergic drugs.
Skin Reactions: In clinical trials with SANCUSO, application site reactions were reported that were generally mild in intensity and did not lead to discontinuation of use. The incidence of reactions was comparable with placebo. If severe reactions, or a generalized skin reaction occur (e.g., allergic rash, including erythematous, macular, papular rash or pruritus), remove the SANCUSO transdermal system.
Increased Drug Exposure with Use of External Heat Sources: Prolonged exposure to heat results in increasing plasma concentrations of granisetron during the period of heat exposure. Do not apply a heat pad or heat lamp over or in the vicinity of the SANCUSO transdermal system and avoid extended exposure to heat.
Phototoxicity with Ultraviolet Light Exposure: Granisetron may be affected by direct natural or artificial sunlight, including sunlamps. An in vitro study using Chinese hamster ovary cells suggests that granisetron has the potential for photogenotoxicity. To avoid a potential skin reaction, advise patients to cover the application site of the transdermal system with clothing if there is a risk of exposure to direct natural or artificial sunlight throughout the period of wear and for 10 days following its removal.
The most common adverse reaction (≥ 3%) is constipation.
You are encouraged to report suspected adverse reactions to
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Cumberland Contact: Shayla Simpson, Cumberland Pharmaceuticals, (615) 255-0068; Kyowa Kirin Contact: Lauren Walrath, Kyowa Kirin North America, (646) 526-4454, email@example.com; Media Contact: Molly Aggas, Dalton Agency, (704) 641-6641, firstname.lastname@example.org