Pramlintide

Pramlintide slows the transit of food through the intestine and, therefore, it should not be administered with other drugs that slow down the intestine (for example, atropine) or slow the absorption of food (for example, acarbose [Precose]). Pramlintide may interfere with (slow) the absorption of orally administered drugs. To avoid this interaction, orally administered drugs that require rapid absorption should be administered 1 hour before or 2 hours after injections of pramlintide. Insulin alters the chemical properties of pramlintide. Therefore, pramlintide and insulin should not be mixed in the same syringe.

Pramlintide is a man-made form of a hormone that occurs naturally in the body. Pramlintide lowers blood sugar in three ways. It slows the rate that food moves from your stomach to your intestines, which keeps your blood sugar from rising too fast. Pramlintide also lowers the amount of glucose (sugar) your liver produces. Lastly, pramlintide triggers the feeling of fullness after meals to help control your appetite and decrease how much food you eat.

Pramlintide is used together with insulin to treat type 1 or type 2 diabetes. Pramlintide is usually given after other diabetes medicines have been tried without success.

Pramlintide may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have a digestive condition called "delayed gastric emptying."

You should not use pramlintide if you cannot recognize symptoms of low blood sugar. Severely low blood sugar (hypoglycemia) may occur within 3 hours after your pramlintide injection. Symptoms may include headache, dizziness, drowsiness, vision problems, hunger, weakness, sweating, confusion, irritability, fast heart rate, or feeling jittery.

You should not use this medicine if you are allergic to pramlintide or metacresol, or:

• if you have a digestive condition called "delayed gastric emptying"; or
• if you cannot recognize symptoms of low blood sugar.

To make sure pramlintide is safe for you, tell your doctor if you have:

• a history of delayed gastric emptying;
• problems with vision (blindness, trouble reading);
• if you are unable to check your blood sugars regularly; or
• if you have had severe hypoglycemia more than once in the past 6 months.

It is not known whether pramlintide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether pramlintide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Pramlintide should not be used in children.

Pramlintide is a prescription medicine used along with insulin to treat type 1 or type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of pramlintide, there are no specific foods that you must exclude from your diet when receiving this medication.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• how you tolerate this medication

The recommended dose range of pramlintide for the treatment of patients with insulin-using type 2 diabetes is 60 mcg-120 mcg .

The recommended dose range of pramlintide for the treatment of dose of patients with type 1 diabetes is 30 mcg-60 mcg.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Seizures.
• Very upset stomach or throwing up.
• Low blood sugar may occur. Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call the doctor right away if any of these signs occur. Follow what you have been told to do if low blood sugar occurs. This may include taking glucose tablets, liquid glucose, or some fruit juices.

• Amylinomimetic
• Antidiabetic Agent

CrCl ≥15 mL/minute: No dosage adjustment necessary.

End-stage renal disease [ESRD]: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); however, need for adjustment not likely since undergoes minimal hepatic metabolism.

Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Androgens: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Exceptions: Danazol. Monitor therapy

Anticholinergic Agents: Pramlintide may enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification

Guanethidine: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy

Insulin: Pramlintide may enhance the hypoglycemic effect of Insulin. Management: Upon initiation of pramlintide, decrease mealtime insulin dose by 50% to reduce the risk of hypoglycemia. Monitor blood glucose frequently and individualize further insulin dose adjustments based on glycemic control. Consider therapy modification

MAO Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Prothionamide: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Quinolone Antibiotics: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolone Antibiotics may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy

Salicylates: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

>10%:

Central nervous system: Headache (5% to 13%)

Endocrine & metabolic: Severe hypoglycemia (type 1 diabetes ≤17%)

Gastrointestinal: Nausea (28% to 48%), anorexia (≤17%), vomiting (7% to 11%)

Miscellaneous: Accidental injury (8% to 14%)

1% to 10%:

Central nervous system: Fatigue (3% to 7%), dizziness (2% to 6%)

Endocrine & metabolic: Severe hypoglycemia (type 2 diabetes ≤8%)

Gastrointestinal: Abdominal pain (2% to 8%)

Hypersensitivity: Hypersensitivity reaction (≤6%)

Neuromuscular & skeletal: Arthralgia (2% to 7%)

Respiratory: Cough (2% to 6%), pharyngitis (3% to 5%)

Postmarketing and/or case reports (Limited to important or life-threatening): Injection site reaction, pancreatitis

Prior to initiating therapy: HbA1c, hypoglycemic history, body weight. During therapy: Pre- and postprandial and bedtime serum glucose, HbA1c, signs and symptoms of hypoglycemia

Adverse events have been observed in animal reproduction studies. Based on in vitro data, pramlintide has a low potential to cross the placenta.

In women with diabetes, maternal hyperglycemia can be associated with congenital malformations as well as adverse effects in the fetus, neonate, and the mother (ACOG 2005; ADA 2017C; Kitzmiller 2008; Metzger 2007). To prevent adverse outcomes prior to conception and throughout pregnancy, maternal blood glucose and HbA1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ACOG 2013; ADA 2017c; Blumer 2013; Kitzmiller 2008). Agents other than pramlintide are currently recommended to treat diabetes in pregnant women (ADA 2017c).

Applies to pramlintide: subcutaneous solution

Along with its needed effects, pramlintide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pramlintide:

• Anxiety
• blurred vision
• chills
• cold sweats
• coma
• confusion
• cool pale skin
• cough
• depression
• difficulty with swallowing
• dizziness
• fast heartbeat
• headache
• hives, itching, or skin rash
• increased hunger
• nausea
• nightmares
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• shakiness
• slurred speech
• tightness in the chest
• unusual tiredness or weakness

Some side effects of pramlintide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty with moving
• inflicted injury
• loss of appetite
• muscle pain or stiffness
• pain in the joints
• stomach pain
• vomiting
• weight loss

• Body aches or pain
• congestion
• dryness or soreness of the throat
• fever
• hoarseness
• runny nose
• tender, swollen glands in the neck
• voice changes

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