SymlinPen (Pramlintide)
SymlinPen 60
Pramlintide Acetate
Select product strength & quantity:
SymlinPen 120
Pramlintide Acetate
Select product strength & quantity:

WHAT IS SYMLINPEN?

SymlinPen (pramlintide acetate) is an injection pen that contains pramlintide acetate. It is used in patients with type 1 or type 2 diabetes mellitus, taking insulin, to better control their blood sugar.

HOW DOES SYMLINPEN WORK?

SymlinPen contains pramlintide acetate that is an analogue of a hormone called amylin. In the body, amylin is produced by the pancreas and is released into the bloodstream at the same time as insulin. Amylin, and by extension pramlintide, slows the secretion of glucagon, thereby delaying food emptying out of the stomach and so reducing appetite. Patients taking pramlintide have lower average blood glucose levels, generally require less insulin, and often lose weight.

INDICATIONS FOR SYMLINPEN

SymlinPen is indicated for the treatment of patients with type 1 or type 2 diabetes mellitus who are making use of insulin given at mealtimes, especially in those who have failed to obtain good glucose control.

DOSAGE

A dose of SymlinPen is different for patients with type 1 diabetes and type 2 diabetes mellitus.

In patients with type 2 diabetes mellitus, the usual dose of insulin should be reduced by half. SymlinPen should then be started at 60 mcg subcutaneously. The dose should be given immediately before each major meal. When starting SymlinPen, patients may report nausea. To prevent this from happening, wait at least three days before increasing the dose of SymlinPen. The dose is then increased from 60 mcg to 120 mcg, given immediately before each major meal. If patients report significant nausea, the dose of SymlinPen should be reduced to 60 mcg.

In patients with type 1 diabetes mellitus, the usual dose of insulin should be reduced by half. SymlinPen should then be started at 15 mcg subcutaneously. To prevent nausea, dose increases should take place every three days. Dose increments should be from 15 to 30, 45, and then 60 mcg. If patients report nausea at 40 or 60 mcg, the dose of SymlinPen should be reduced to 30 mcg. If this dose still causes significant nausea, therapy may have to be discontinued.

WARNINGS AND PRECAUTIONS

Severe low blood sugar (hypoglycemia)

SymlinPen contains pramlintide acetate that contributes to a reduction in blood glucose levels in the blood. When used with insulin, especially in patients with type 1 diabetes mellitus, there is a risk for the development of severe hypoglycemia. Severe hypoglycemia is normally seen within three hours of receiving a SymlinPen injection. Severe hypoglycemia is potentially life-threatening, especially if this occurs while operating a motor vehicle or heavy machinery. Therefore, it is critical to select appropriate patients and to carefully educate patient on the use of SymlinPen, before starting treatment.

Patient selection

It is critical to select appropriate patients when using SymlinPen. Type 1 or type 2 diabetes mellitus patients who are using insulin at mealtimes must have ongoing care by a healthcare worker who is skilled in using insulin to control diabetes and must have poor control of their diabetes despite being on insulin. Patients with any of the following factors should not be put on SymlinPen therapy:

  • Inability to follow their current insulin prescription
  • Inability to measure their blood glucose as instructed
  • HbA1c >9%
  • Have had repeated episodes of low blood glucose in the last 6 months that has required medical assistance.
  • Has confirmed gastroparesis
  • Requires the use of drugs such as metoclopramide to assist the motility of the gastrointestinal tract.
  • Pediatric patients

Care should be taken in patients who have visual impairment or who will struggle to select dosages and to inject themselves.

Medication taken at the same time

SymlinPen slows the rate at which the stomach empties. This can cause the absorption of medication taken at the same time to be delayed. Take oral medication at least one hour before injecting SymlinPen, or two hours after injection.

SPECIAL POPULATIONS

Pregnancy

SymlinPen has not been studied well in pregnant women. Evidence suggests that SymlinPen does not affect the fetus. Its use in pregnancy should only be considered if the benefits outweigh the potential fetal risk.

Breastfeeding

It is not known if SymlinPen is excreted in breast milk. Only use SymlinPen if the benefits to the mother outweigh the possible risk to the infant.

Pediatrics

The safety of SymlinPen in pediatric patients have not been established.

Elderly

SymlinPen has been studied in patients up to the age of 84. There seems to be no difference in the safety of SymlinPen when compared to younger patients, but it remains possible that older patients may have a greater drug sensitivity. Careful monitoring should be done in elderly patients to minimize the risk of severe hypoglycemia.

Renal impairment

The dose of SymlinPen does not need to be changed in patients with severe renal impairment. SymlinPen has not been studied in patients with renal failure.

Hepatic impairment

SymlinPen has not been studied in patients with hepatic impairment.

CONTRAINDICATIONS

Patients with any of the following factors should not be put on SymlinPen therapy:

  • Inability to follow their current insulin prescription
  • Inability to measure their blood glucose as instructed
  • HbA1c >9%
  • Have had repeated episodes of low blood glucose in the last 6 months that has required medical assistance.
  • Has confirmed gastroparesis
  • Requires the use of drugs such as metoclopramide to assist the motility of the gastrointestinal tract.
  • Pediatric patients

SIDE EFFECTS

Common side effects of SymlinPen include:

  • Nausea
  • Lack of appetite
  • Local skin injury from injection
  • Vomiting
  • Joint pain
  • Fatigue
  • Local skin rash
  • Dizziness

Less common side effects include:

  • Severe hypoglycemia
  • Severe local skin reactions at the site of injection

If any of these side effects are noticed, a doctor should be contacted immediately.

DRUG INTERACTIONS

Certain drugs may interact with SymlinPen. These include:

  • Insulin
  • All medications taken orally
  • Drugs affecting gastric emptying (anticholinergics e.g., atropine)
  • Drugs slowing intestinal absorption (alpha-glucosidase inhibitors)
  • Drugs impacting glucose metabolism
    • Oral anti-diabetic agents
    • Angiotensin-converting enzyme inhibitors (ACE)
    • Fibrates
    • Monoamine oxidase inhibitors
    • Propoxyphene
    • Salicylates
    • Sulfonamide antibiotics

FREQUENTLY ASKED QUESTIONS

SymlinPen is provided as a disposable sterile 1000 mcg/ml multidose pen-injector. It comes as a 1.5 ml 60 pen-injector or as a 2.7 ml 120 pen-injector.

The dose SymlinPen is different for patients with type 1 diabetes and type 2 diabetes mellitus.

In patients with type 2 diabetes mellitus, the usual dose of insulin should be reduced by half. SymlinPen should then be started at 60 mcg subcutaneously. The dose should be given immediately before each major meal. When starting SymlinPen, the patient may report nausea. To prevent this from happening, wait at least three days before increasing the dose of SymlinPen. The dose is then increased from 60 mcg to 120 mcg, given immediately before each major meal. If the patient reports significant nausea, the dose of SymlinPen should be reduced to 60 mcg.

In patients with type 1 diabetes mellitus, the usual dose of insulin should be reduced by half. SymlinPen should then be started at 15 mcg subcutaneously. To prevent nausea, dose increases should take place every three days. Dose increments should be from 15 to 30, 45, and then 60 mcg. If the patient reports nausea at 40 or 60 mcg, the dose of SymlinPen should be reduced to 30 mcg. If this dose still causes significant nausea, therapy may have to be discontinued.

The SymlinPen is given as an injection below the skin. The injection should be given before eating a large meal. Make sure the SymlinPen is at room temperature, as this reduces the chance of getting an infection at the injection site. Before injecting SymlinPen, make sure that the solution is clear and has not changed color. Inject the dose from the SymlinPen below the skin, using either your stomach or your thigh as the injection site. It is not recommended that you use your arm – the absorption of the medication is too variable from this site. Make sure that you use different sites for the injection and do not use the same place when you inject your insulin dose. Always give your dose of insulin and SymlinPen as two separate injections. Never mix SymlinPen and your usual insulin together.

Persons with severe hypersensitivity to SymlinPen constituents should not take the medication. Patients who have no awareness of hypoglycemia or who have confirmed gastroparesis should not take SymlinPen.

Should you miss a dose of SymlinPen, do not take the dose. Instead, wait until you again plan to eat a major meal and then inject SymlinPen before you start eating.

You should stop using SymlinPen if you experience:

  • repeated episodes of unexpected hypoglycemia that requires medical help
  • ongoing severe nausea,
  • difficulty in monitoring your blood glucose concentrations,
  • difficulty in adjusting your insulin doses,
  • difficulty in making booked appointments with your doctor or at your clinic.

Common side effects of SymlinPen include:

  • Nausea
  • Lack of appetite
  • Local skin injury from injection
  • Vomiting
  • Joint pain
  • Fatigue
  • Local skin rash
  • Dizziness

Less common side effects include:

  • Severe hypoglycemia
  • Severe local skin reactions at the site of injection

If any of these side effects are noticed, a doctor should be contacted immediately.

If you experience severe side effects, immediately contact your doctor or go to the nearest emergency health care facility.

Your SymlinPen should be refrigerated at 2°C to 8 °C and protected from light when not used. It should not be frozen. Do not use SymlinPen if it has been frozen. After your first use of SymlinPen, the injector can be stored at room temp or refrigerated at less than 30°C for 30 days.