Symlin

DRUG DESCRIPTION

SYMLIN® (pramlintide acetate) Injection is an antihyperglycemic drug for use in patients with diabetes treated with insulin. Pramlintide is a synthetic analog of human amylin, a naturally occurring neuroendocrine hormone synthesized by pancreatic beta cells that contributes to glucose control during the postprandial period. Pramlintide is provided as an acetate salt of the synthetic 37-amino acid polypeptide, which differs in amino acid sequence from human amylin by replacement with proline at positions 25 (alanine), 28 (serine), and 29 (serine).

The structural formula of pramlintide acetate is as shown:


Lys-Cys-Asn-Thr-Ala-Thr-Cys-Ala-Thr-Gln-Arg-Leu-Ala-Asn-Phe- Leu-Val-His-Ser-Ser-Asn-Asn-Phe-Gly-Pro-Ile-Leu-Pro-Pro-Thr- Asn-Val-Gly-Ser-Asn-Thr-Tyr-NH2 acetate (salt) with a disulfide bridge between the two Cys residues.

Pramlintide acetate is a white powder that has a molecular formula of C171H267N51O53S2· x C2H4O2 (3 x 8); the molecular weight is 3949.4. Pramlintide acetate is soluble in water.

SYMLIN (pramlintide acetate injection) is formulated as a clear, isotonic, sterile solution for subcutaneous (SC) administration. SYMLIN (pramlintide acetate injection) vials contain 0.6 mg/mL of pramlintide (as acetate), 2.25 mg/mL of metacresol as a preservative, D-mannitol as a tonicity modifier, and acetic acid and sodium acetate as pH modifiers. SYMLIN (pramlintide acetate injection) has a pH of approximately 4.0.

What are the possible side effects of pramlintide (Symlin, SymlinPen 120, SymlinPen 60)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe nausea that lasts for 3 to 7 days; or
  • more frequent high blood sugar levels.

Less serious side effects may include:

  • runny or stuffy nose, sore throat, cough;
  • diarrhea, nausea, vomiting, loss of...

Read All Potential Side Effects and See Pictures of Symlin »

What are the precautions when taking pramlintide acetate injection (Symlin)?

Before using pramlintide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the preservative metacresol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medication, consult your doctor or pharmacist if you have: stomach/intestinal disorders (e.g., digestion problems such as gastroparesis).

This medication should not be used by people who are unable to tell when they have symptoms of low blood sugar (e.g., children).

Before using pramlintide, tell your doctor or pharmacist your medical history, especially of: attacks of low blood...

Read All Potential Precautions of Symlin »


Symlin Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, tiredness, and upset stomach may occur as your body adjusts to the medication. Nausea can be reduced by starting at a low dose and increasing the dose slowly. Redness, swelling, and itching at the injection site may occur and usually go away in a few days. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using pramlintide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the preservative metacresol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medication, consult your doctor or pharmacist if you have: stomach/intestinal disorders (e.g., digestion problems such as gastroparesis).

This medication should not be used by people who are unable to tell when they have symptoms of low blood sugar (e.g., children).

Before using pramlintide, tell your doctor or pharmacist your medical history, especially of: attacks of low blood sugar (hypoglycemia) that required treatment.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages because alcohol can affect your blood sugar.

Though pramlintide does not cause low blood sugar by itself, it may increase the risk of an attack of low blood sugar because it is used with insulin. Be sure you are aware of the signs of low blood sugar and know how to prevent and treat it.

Symptoms of low blood sugar include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling hands/feet, or hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, quickly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor.

If symptoms of either high or low blood sugar occur, tell your doctor immediately. Your medication dosage may need to be changed.

It may be harder to control your blood sugar when your body is stressed (e.g., due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if pramlintide passes into breast milk. Consult your doctor before breast-feeding.


Symlin Patient Information Including Side Effects

Brand Names: Symlin, SymlinPen 120, SymlinPen 60

Generic Name: pramlintide (Pronunciation: PRAM lin tide)

  • What is pramlintide (Symlin)?
  • What are the possible side effects of pramlintide (Symlin)?
  • What is the most important information I should know about pramlintide (Symlin)?
  • What should I discuss with my doctor before using pramlintide (Symlin)?
  • How should I use pramlintide (Symlin)?
  • What happens if I miss a dose (Symlin)?
  • What happens if I overdose (Symlin)?
  • What should I avoid while using pramlintide (Symlin)?
  • What other drugs will affect pramlintide (Symlin)?
  • Where can I get more information?

What is pramlintide (Symlin)?

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

What are the possible side effects of pramlintide (Symlin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe nausea that lasts for 3 to 7 days; or
  • more frequent high blood sugar levels.

Less serious side effects may include:

  • runny or stuffy nose, sore throat, cough;
  • diarrhea, nausea, vomiting, loss of appetite;
  • headache, dizziness, tired feeling; or
  • joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about pramlintide (Symlin)?

Do not mix pramlintide and insulin together in the same syringe.

You will need to use a lower dose of insulin than you used before you started using pramlintide. Your doctor will determine your correct dose. Do not change your doses or medication schedule without your doctor's advice.

Call your doctor if you have severe nausea that lasts for several days. This may be a sign that your dose is too high.

If you skip a meal, do not take your dose of pramlintide. Wait until your next meal.

If you stop using pramlintide for a short time, you may need to restart the medication at a lower dose. Follow your doctor's instructions.

Take care not to let your blood sugar get too low, causing hypoglycemia. Severe hypoglycemia may occur within 3 hours after your pramlintide injection. Carry a piece of hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.

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