Dr. Reddy's Laboratories Announces the Launch of Icosapent Ethyl Capsules, 1 Gram in the U.S. Market
22 June 2021 - 4:07PM
Business Wire
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE:
RDY, NSEIFSC: DRREDDY, along with its subsidiaries together
referred to as “Dr. Reddy’s”) today announced the launch of
Icosapent Ethyl Capsules, 1 gram approved by the U.S. Food and Drug
Administration (USFDA).
Dr. Reddy’s Icosapent Ethyl Capsules, 1 gram is approved for the
following indication: as an adjunct to diet to reduce triglyceride
(TG) levels in adult patients with severe (≥ 500 mg/dL)
hypertriglyceridemia.
Please note that Dr. Reddy’s Icosapent Ethyl Capsules is not
approved for the following indication: as an adjunct to maximally
tolerated statin therapy to reduce the risk of myocardial
infarction, stroke, coronary revascularization, and unstable angina
requiring hospitalization in adult patients with elevated
triglyceride (TG) levels (≥ 150 mg/dL) and established
cardiovascular disease or diabetes mellitus and two or more
additional risk factors for cardiovascular disease.
Limitations of Use: The effect of
Icosapent Ethyl Capsules on the risk for pancreatitis in patients
with severe hypertriglyceridemia has not been determined.
Dr. Reddy’s Icosapent Ethyl is available in 1 gram capsules in
bottle count size of 120’s count.
Please click here to see the full prescribing information along
with the approved indication for Dr. Reddy’s Icosapent Ethyl
Capsules:
https://www.drreddys.com/pi/icosapent-ethyl-1g-pi.pdf.
Important Safety Information: Icosapent
Ethyl Capsules, 1 Gram
What Important Information Should I Know About Icosapent
Ethyl Capsules, 1 Gram?
- Icosapent Ethyl is associated with an increased risk of heart
arrhythmias (atrial fibrillation or atrial flutter) requiring
hospitalization
- Potential allergic reactions in patients with fish and/or
shellfish allergy
- Please discontinue and seek medical attention if you experience
any reactions
- Icosapent Ethyl is associated with an increased risk of
bleeding. The incidence of bleeding is greater in patients
receiving concomitant antithrombotic medications, such as aspirin,
clopidogrel, or warfarin
Who Should Not Use Icosapent Ethyl Capsules, 1 Gram?
- Icosapent Ethyl Capsules should not be used in patients with
known hypersensitivity (e.g. anaphylactic reaction) to Icosapent
Ethyl or any of its ingredients
What Should I Tell My Healthcare Provider Before Taking
Icosapent Ethyl Capsules, 1 Gram?
Before taking Icosapent Ethyl Capsules, tell your doctor if
you:
- Have diabetes
- Have been diagnosed with low thyroid levels
(hypothyroidism)
- Have a known liver condition
- Have a known pancreas condition
- Have fish and/or shellfish allergies
- Are pregnant, or planning to become pregnant
- Are breastfeeding or plan to breastfeed
Provide your doctor with a complete list of medications you
take, including prescription and over-the-counter medicines,
vitamins, and dietary or herbal supplements. Icosapent Ethyl
Capsules can interact with certain other medicines that you are
taking.
Tell your doctor if you take medicines that affect your blood
clotting (anticoagulants or blood thinners).
What Are the Possible Adverse Reactions of Icosapent Ethyl
Capsules, 1 Gram?
Call your doctor or get emergency help right away if you
develop:
- Heart arrhythmias (atrial fibrillation or atrial
flutter) - Heart arrhythmias which can be serious and cause
hospitalization have happened in people who take Icosapent Ethyl
Capsules, especially in people who have heart (cardiovascular)
disease or diabetes with a risk factor for heart (cardiovascular)
disease, or who have had heart arrhythmias in the past. Tell your
doctor if you get any symptoms of heart arrhythmias such as feeling
as if your heart is beating fast and irregular, lightheadedness,
dizziness, shortness of breath, chest discomfort, or you faint
- Potential allergic reactions if you are allergic to fish
and/or shellfish
- Bleeding - Serious bleeding may occur while using
Icosapent Ethyl Capsules. Increased risk of bleeding may occur if
also taking blood thinners
If you have a liver condition and are taking Icosapent Ethyl
Capsules, your doctor should do blood tests during treatment.
The most common adverse reactions include:
- Muscle and joint pain (musculoskeletal pain)
- Swelling of the hands, legs, or feet (peripheral edema)
- Constipation
- Gout
- Heart arrhythmias (atrial fibrillation)
Please refer to the Package Insert for full prescribing
information for Icosapent Ethyl Capsules.
These are not all of the possible side effects of Icosapent
Ethyl Capsules. Call your doctor for medical advice about side
effects. For more information, ask your healthcare provider or
pharmacist. You are encouraged to report negative side effects of
prescription drugs. To report suspected side effects, call Dr.
Reddy’s Laboratories Medical Information Hotline at 1-888-DRL-DRUG
(1-888-375-3784) or via email to medinfo@drreddys.com or contact
the US FDA at 1-800-FDA-1088 (1-800-332-1088) or online at
http://www.fda.gov/safety/medwatch.
Indication and Usage for Icosapent Ethyl Capsules, 1
Gram
- Icosapent Ethyl Capsules is indicated for: as an adjunct to
diet to reduce triglyceride (TG) levels in adult patients with
severe (≥ 500 mg/dL) hypertriglyceridemia.
Please note that Dr. Reddy’s Icosapent Ethyl Capsules is not
approved for the following indication: as an adjunct to maximally
tolerated statin therapy to reduce the risk of myocardial
infarction, stroke, coronary revascularization, and unstable angina
requiring hospitalization in adult patients with elevated
triglyceride (TG) levels (≥ 150 mg/dL) and established
cardiovascular disease or diabetes mellitus and two or more
additional risk factors for cardiovascular disease.
Limitations of Use: The effect of
Icosapent Ethyl Capsules on the risk for pancreatitis in patients
with severe hypertriglyceridemia has not been determined.
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INVESTOR RELATIONS AMIT AGARWAL amita@drreddys.com
MEDIA RELATIONS USHA IYER ushaiyer@drreddys.com
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