Terms and Conditions:

Eligible patients pay as little as $25/month and no more than $95/month. Maximum benefit is $522 per fill or $7,308 per year (up to 14 fills) (the 'Program Maximum'). After the Program Maximum, the patient will be responsible for the difference. This offer is valid only for those with commercial insurance and who have a valid prescription. This offer is not valid under Medicare, Medicaid, or any other federal or state program, for cash-paying patients, or where a plan reimburses you for the entire cost of your prescription drug. This offer is not transferable, and cannot be combined with any other offer. This offer is not health insurance and is only valid for patients in the 50 United States, Washington DC, Puerto Rico, Guam and Virgin Islands. Void where prohibited or restricted. Additional terms and conditions may apply. This offer may change at any time, without notice. When you use this card, you are certifying that you understand the program rules, regulations and these Terms and Conditions, that you have responded truthfully to questions when activating the card, and that you will disclose and report the use of this offer as may be required by your insurer. It is illegal to sell, purchase, trade, counterfeit, duplicate, or reproduce, or offer to sell, purchase, trade, counterfeit, duplicate, or reproduce the card. This card must be presented to the pharmacist with a valid prescription to participate in this program. If you have any questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call the RIOMET ER Savings program at 855-699-8695 (8:00 am - 8:00 pm EST, Monday-Friday). Sun Pharma reserves the right to modify or discontinue this offer at any time without notice.

 

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INDICATIONS AND USAGE

Riomet ER (metformin hydrochloride for extended-release oral suspension) is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.

IMPORTANT SAFETY INFORMATION

WARNING: LACTIC ACIDOSIS

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excessive alcohol intake, and hepatic impairment.

Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high-risk groups are provided.

If metformin-associated lactic acidosis is suspected, immediately discontinue Riomet ER and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

CONTRAINDICATIONS

Riomet ER is contraindicated in patients with:
  • Severe renal impairment (eGFR below 30 mL/min/1.73 m2)
  • Hypersensitivity to metformin
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma

WARNINGS AND PRECAUTIONS

  • Lactic Acidosis: See boxed warning
  • Vitamin B12 Deficiency: Metformin may lower vitamin B12 levels. Individuals with inadequate vitamin B12 or calcium intake or absorption appear to be predisposed to developing subnormal vitamin B12 levels. Measure hematologic parameters on an annual basis and vitamin B12 at 2 to 3 year intervals in patients on Riomet ER and manage any abnormalities.
  • Hypoglycemia With Concomitant Use With Insulin and Insulin Secretagogues: Insulin and insulin secretagogues (eg, sulfonylurea) are known to cause hypoglycemia. Riomet ER may increase the risk of hypoglycemia when combined with insulin and/or an insulin secretagogue. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with Riomet ER.

ADVERSE REACTIONS

The most common adverse reactions (>5.0%) are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache.

DRUG INTERACTIONS

  • Carbonic Anhydrase Inhibitors: may increase the risk of lactic acidosis. Consider more frequent monitoring of these patients
  • Drugs That Reduce Metformin Clearance: (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin. Consider the benefits and risks of concomitant use with Riomet ER
  • Alcohol and Medications Containing Alcohol: Alcohol is known to increase the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake while receiving Riomet ER
  • Drugs Affecting Glycemic Control: Certain drugs (eg, thiazides and other diuretics) tend to produce hyperglycemia and may lead to loss of glycemic control. When such drugs are administered concomitantly with Riomet ER , observe the patient closely for loss of blood glucose control. When such drugs are withdrawn from a patient receiving Riomet ER, observe the patient closely for hypoglycemia

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Poorly controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications. Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity
  • Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy. Riomet ER can cause ovulation, increasing the chance of getting pregnant
  • Geriatric Use: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range to reflect the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy, and the higher risk of lactic acidosis. Assess renal function more frequently in elderly patients
  • Hepatic Impairment: Use of metformin in patients with hepatic impairment has been has been associated with some cases of lactic acidosis. Riomet ER is not recommended in patients with hepatic impairment

To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


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