Data from FDA - Curated by EPG Health - Last updated 20 December 2016

Indication(s)

1 INDICATIONS AND USAGE Suprenza is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

Below is a chart of body mass index (BMI) based on various heights and weights.

BMI is calculated by taking the patient 's weight, in kilograms (kg), divided by the patient 's height, in meters (m), squared.

Metric conversions are as follows:

pounds?

2.2 = kg; inches x 0.0254 = meters.

Height (feet, inches) BODY MASS INDEX (BMI), kg/ m2 Weight (pounds) 5'0” 5'3” 5'6” 5'9” 6'0” 6'3” 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220

43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31 The limited usefulness of agents of this class, including Suprenza, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.

Suprenza is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

(1) The limited usefulness of agents of this class, including Suprenza, should be measured against possible risk factors inherent in their use.

(1)

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Advisory information

contraindications

4 CONTRAINDICATIONS History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) During or within 14 days following the administration of monoamine oxidase inhibitors Hyperthyroidism Glaucoma Agitated states History of drug abuse Pregnancy [see Use in Specific Populations (8.1)] Nursing [see Use in Specific Populations (8.3)] Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) (4) During or within 14 days following the administration of monoamine oxidase inhibitors (4) Hyperthyroidism (4) Glaucoma (4) Agitated states (4) History of drug abuse (4) Pregnancy (4

8.1) Nursing (4, 8.3) Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines (4)

Adverse reactions

6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: - Primary pulmonary hypertension [see Warnings and Precautions (5.2)] - Valvular heart disease [see Warnings and Precautions (5.3)] - Effect on the ability to engage in potentially hazardous tasks [see Warnings and Precautions (5.5)] - Withdrawal effects following prolonged high dosage administration [see Drug Abuse and Dependence (9.3)] The following adverse reactions to phentermine have been identified: Cardiovascular Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events.

Central Nervous System Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis.

Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.

Allergic Urticaria.

Endocrine Impotence, changes in libido.

Adverse events have been reported in the cardiovascular, central nervous, gastrointestinal, allergic, and endocrine systems.

(6) To report SUSPECTED ADVERSE REACTIONS, contact Akrimax Pharmaceuticals, LLC at 1-888-383-1733 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Usage information

Dosing and administration

2 DOSAGE AND ADMINISTRATION Exogenous Obesity Dosage should be individualized to obtain an adequate response with the lowest effective dose.

The usual adult dose is one tablet as prescribed by the physician, administered in the morning, with or without food.

Suprenza is not recommended for use in pediatric patients less than or equal to 16 years of age.

Late evening medication should be avoided because of the possibility of resulting insomnia.

With dry hands, gently remove the Suprenza (phentermine hydrochloride ODT) tablet from the bottle.

Immediately place the Suprenza tablet on top of the tongue where it will dissolve, then swallow with or without water.

Dosage should be individualized to obtain an adequate response with the lowest effective dose.

(2) Late evening administration should be avoided (risk of insomnia).

(2) Suprenza can be taken with or without food (12.3)

Use in special populations

8 USE IN SPECIFIC POPULATIONS Nursing mothers: Discontinue drug or nursing taking into consideration importance of drug to mother.

(4, 8.3) Pediatric use: Safety and effectiveness not established.

(8.4) Geriatric use: Due to substantial renal excretion, use with caution.

(8.5) Use caution when administering Suprenza to patients with renal impairment (8.6) 8.1 Pregnancy Pregnancy Category X Suprenza is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm.

A minimum weight gain , and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to obligatory weight gain that occurs in maternal tissues during pregnancy.

Phentermine has pharmacologic activity similar to amphetamine (d - and dll-amphetamine) [see Clinical Pharmacology (12.1)].

Animal reproduction studies have not been conducted with phentermine.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

8.3 Nursing Mothers It is not known if Suprenza is excreted in human milk; however, other amphetamines are present in human milk.

Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended.

8.

5 Geriatric Use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6 Renal Impairment Suprenza was not studied in patients with renal impairment.

Based on the reported excretion of phentermine in urine, exposure increases can be expected in patients with renal impairment.

Use caution when administering Suprenza to patients with renal impairment [see Clinical Pharmacology (12.3)].

Pregnancy and lactation
8.3 Nursing Mothers It is not known if Suprenza is excreted in human milk; however, other amphetamines are present in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Interactions

7 DRUG INTERACTIONS Monoamine oxidase inhibitors: Risk of hypertensive crisis.

(4, 7.1) Alcohol: Consider potential interaction (7.2) Insulin and oral hypoglycemics: Requirements may be altered.

(7.3) Adrenergic neuron blocking drugs: Hypotensive effect may be decreased by Suprenza.

(7.4) 7.1 Monoamine Oxidase I nhibitors Use of Suprenza is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.

7.2 Alcohol Concomitant use of alcohol with Suprenza may result in an adverse drug reaction.

7.3 Insulin and Oral Hypoglycemic Medications Requirements may be altered [see Warnings and Precautions (5.9)].

7.4 Adrenergic Neuron Blocking Drugs Suprenza may decrease the hypotensive effect of adrenergic neuron blocking drugs.

More information

Category Value
Authorisation number NDA202088
Orphan designation No
Product NDC 24090-722,24090-720,24090-721
Date Last Revised 30-06-2013
Type HUMAN PRESCRIPTION DRUG
RXCUI 1249083
Marketing authorisation holder Akrimax Pharmaceuticals, LLC