Brand Name
SymlinPen
Generic Name
Pramlintide Acetate
View Brand Information FDA approval date: January 08, 2015
Classification: Amylin Analog
Form: Injection
What is SymlinPen (Pramlintide Acetate)?
For people living with type 1 or type 2 diabetes, managing blood sugar levels with insulin is a daily reality. Yet, even with diligent monitoring and insulin use, achieving stable glucose control can be a constant challenge, especially after meals. Those frustrating post-meal spikes can feel unpredictable and difficult to manage. This is where a unique, adjunctive therapy called SymlinPen (pramlintide acetate) can play a supportive role.
SymlinPen is not insulin, nor is it a replacement for it. Instead, it is an injectable prescription medication that works alongside insulin to improve glucose control. It belongs to a class of drugs known as amylin analogs, meaning it is a synthetic version of a natural hormone called amylin. In people without diabetes, amylin and insulin are released together by the pancreas to manage blood sugar. SymlinPen is designed for patients who use mealtime insulin but still struggle to reach their blood sugar targets, offering another tool to help smooth out the peaks and valleys of daily glucose management.
What does SymlinPen do?
SymlinPen is approved by the U.S. Food and Drug Administration (FDA) as an add-on treatment for adults with either type 1 or type 2 diabetes who use mealtime insulin. Its primary purpose is to improve glycemic control, particularly after eating.
By adding SymlinPen to their insulin regimen, patients may experience:
- Reduced Post-Meal Blood Sugar Spikes: It helps to prevent the sharp rise in glucose that can occur after eating a meal.
- Lower Hemoglobin A1c Levels: By improving overall glucose control, it can help lower A1c, which is a key measure of long-term blood sugar management.
- Potential for Reduced Mealtime Insulin Doses: Because it helps manage post-meal glucose, some patients may find they need less mealtime insulin.
- Modest Weight Loss: It can help promote a feeling of fullness, which may lead to eating less and a slight reduction in body weight.
Clinical studies have shown that when added to insulin therapy, SymlinPen significantly improves A1c levels and reduces post-meal glucose excursions compared to insulin alone, providing a valuable option for fine-tuning diabetes care (AstraZeneca Pharmaceuticals LP, 2021).
How does SymlinPen work?
SymlinPen works by mimicking the actions of the natural hormone amylin. In a person without diabetes, the pancreas releases both insulin and amylin in response to a meal. While insulin helps cells absorb sugar from the blood, amylin helps to regulate the speed at which sugar enters the blood in the first place. Many people with diabetes either don’t produce amylin or don’t produce enough of it.
SymlinPen helps manage blood sugar by:
- Slowing gastric emptying: Delays carbohydrate absorption, preventing rapid blood sugar spikes after meals.
- Suppressing glucagon secretion: Blocks the release of stored sugar from the liver, reducing excess blood sugar.
- Promoting satiety: Increases feelings of fullness, aiding in smaller meal portions and calorie reduction.
By performing these three actions, SymlinPen provides a multi-faceted approach to improving post-meal blood sugar control that complements the action of insulin.
SymlinPen side effects
The most significant risk associated with SymlinPen is a boxed warning, the FDA’s strongest warning, for the risk of severe hypoglycemia (dangerously low blood sugar). This risk is highest when SymlinPen is used with insulin.
Severe hypoglycemia risk is highest within three hours post-injection. When starting SymlinPen, reduce your usual mealtime insulin dose by 50% as instructed by your doctor. Frequent blood sugar monitoring, especially pre- and post-meals, is crucial to prevent low blood sugar.
The most common side effect of SymlinPen is nausea, especially when starting the medication. This is often mild to moderate and tends to decrease over time. Other common side effects may include:
- Decreased appetite
- Vomiting
- Headache
- Injection site reactions (redness, swelling)
Do not use SymlinPen if you have gastroparesis or hypoglycemia unawareness. Regular blood sugar testing is essential. Seek immediate medical attention for severe, unmanageable hypoglycemia symptoms like confusion, seizures, or loss of consciousness.
SymlinPen dosage
SymlinPen is an injectable medication that comes in a prefilled pen device. It is administered as a subcutaneous injection (an injection under the skin) into the abdomen or thigh.
Crucially, SymlinPen is injected immediately before major meals (meals containing at least 250 calories or 30 grams of carbohydrates). It is a separate injection from insulin and should never be mixed in the same syringe.
Your doctor will gradually increase your SymlinPen dose to minimize nausea. Close monitoring of blood glucose is essential, especially when starting or changing doses of SymlinPen or insulin. Mealtime insulin doses must be reduced at the start of SymlinPen, and your doctor will guide further adjustments.
Does SymlinPen have a generic version?
No, there is currently no generic version of SymlinPen (pramlintide acetate) available. However, international versions may exist in other markets. SymlinPen is a biologic medication, and a biosimilar (the equivalent of a generic) has not been approved by the FDA. Therefore, it is only available under the brand name SymlinPen.
Conclusion
For individuals with type 1 or type 2 diabetes who are already using mealtime insulin but still struggle with post-meal blood sugar control, SymlinPen offers a unique and effective adjunctive therapy. By mimicking the natural hormone amylin, it helps to smooth out glucose spikes, lower A1c, and may assist with weight management.
However, its use requires a significant commitment to safety. The risk of severe hypoglycemia is real and must be managed through careful insulin dose adjustments and frequent blood sugar monitoring. When used under the close guidance of a healthcare provider, SymlinPen can be a valuable addition to a comprehensive diabetes management plan, helping you achieve better control and take another positive step on your health journey.
References
- AstraZeneca Pharmaceuticals LP. (2021). SYMLINPEN® (pramlintide acetate) injection Prescribing Information. U.S. Food and Drug Administration. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021342s031lbl.pdf
- Mayo Clinic. (2024). Pramlintide (Subcutaneous Route). Retrieved from https://www.mayoclinic.org/drugs-supplements/pramlintide-subcutaneous-route/side-effects/drg-20065611
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Brand Information
SymlinPen (pramlintide acetate)
WARNING: SEVERE HYPOGLYCEMIA
SYMLIN use with insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia occurs, it is seen within 3 hours following a SYMLIN injection. Serious injuries may occur if severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities. Appropriate patient selection, careful patient instruction, and insulin dose reduction are critical elements for reducing this risk.
1INDICATIONS AND USAGE
SYMLIN is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy.
2DOSAGE FORMS AND STRENGTHS
SYMLIN is supplied as a sterile injection in the following dosage forms:
- 1.5 mL disposable multidose SymlinPen
- 2.7 mL disposable multidose SymlinPen
3CONTRAINDICATIONS
SYMLIN is contraindicated in patients with any of the following:
- serious hypersensitivity reaction to SYMLIN or to any of its product components.
- hypoglycemia unawareness.
- confirmed gastroparesis.
4ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
4.1Postmarketing Experience
The following adverse reactions have been identified during post-approval use of SYMLIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Injection site reactions
- Pancreatitis
5OVERDOSAGE
Single 10 mg doses of SYMLIN (83 times the maximum recommended dose of 120 mcg for patients with type 2 diabetes) were administered to 3 healthy volunteers. All 3 individuals reported severe nausea associated with vomiting, diarrhea, vasodilatation, and dizziness. No hypoglycemia was reported. Pramlintide has a short half-life (approximately 48 minutes in healthy individuals). Initiate supportive measures in the case of overdose.
6DESCRIPTION
SYMLIN
The structural formula of pramlintide acetate is shown below:
Pramlintide acetate is a white powder that has a molecular formula of C
SYMLIN is formulated as a clear, isotonic, sterile solution for subcutaneous administration. The disposable multidose SymlinPen
7CLINICAL STUDIES
A total of 2333 patients with type 1 diabetes and 1852 patients with type 2 diabetes received SYMLIN in controlled clinical trials.
7.1Type 1 Diabetes
The efficacy and safety of SYMLIN were evaluated in 3 (26-52-week), randomized, double-blind, placebo-controlled trials in patients with type 1 diabetes. In these studies, insulin adjustments were minimized in order to isolate the SYMLIN effect with insulin adjustments allowed, at the investigator's discretion, when excessive hypoglycemia was encountered. Patients participating in these 3 trials had a mean age of 40 years, a mean duration of diabetes of 17 years, and a mean body mass index of 25.9 kg/m
Table 6 summarizes the 6-month results for those patients assigned to the 30 or 60 mcg dose of SYMLIN or placebo.
In the three studies, from a mean baseline body weight of 75.3 kg, 73.3 kg, and 76.6 kg, respectively, after randomization there were corresponding mean reductions of –0.8 kg, –1.6 kg, and –1.3 kg (60 mcg TID) and –0.8 kg (60 mcg QID) in the SYMLIN treatment group compared to mean increases of +0.8 kg, +0.4 kg, and +0.7 kg in the placebo treatment group.
7.1.1SYMLIN Dose-Titration Study
A dose-titration study of SYMLIN was conducted in patients with type 1 diabetes who had a mean age of 41 years, a mean duration of diabetes of 20 years, and a mean body mass index of 28 kg/m
Table 7 summarizes the 6-month results for the dose-titration study.
In the dose titration study, from mean baseline body weight of 81.5 kg, after randomization there was a mean reduction of –1.33 kg in the SYMLIN treatment group compared to a mean increase of +1.25 kg in the placebo treatment group.
7.2Type 2 Diabetes
The efficacy and safety of SYMLIN were evaluated in 2 (a 26-week and a 52-week) randomized, double-blind, placebo-controlled trials in patients with type 2 diabetes. These trials enrolled patients with inadequate glycemic control (HbA1c >8%) on fixed dose insulin. In both trials, SYMLIN or placebo was added to existing insulin therapies. Concomitant use of a sulfonylurea and/or metformin was permitted. Insulin doses were to be kept as stable as possible throughout the treatment period to isolate the SYMLIN effect.
Patients participating in these 2 trials had a mean age of 57 years and a mean duration of diabetes of 13 years. Mean body mass index was 32.9 kg/m
Table 8 summarizes the 6-month results for each trial for those patients assigned to the 120 mcg dose of SYMLIN and placebo.
In both studies, from a mean baseline body weight of 96.7 kg, and 85.6 kg, respectively, after randomization there were corresponding mean reductions of –1.4 kg, and –1.6 kg in the SYMLIN treatment group compared to mean increases of +0.3 kg, and +0.1 kg in the placebo treatment group.
8HOW SUPPLIED/STORAGE AND HANDLING
SYMLIN Injection is available in the following package sizes:
- SymlinPen
- SymlinPen
8.1Storage and Handling
SYMLIN pen-injectors not in use: Refrigerate (2°C to 8°C; 36°F to 46°F), and protect from light. Do not freeze. Do not use if product has been frozen. Unused SYMLIN (opened or unopened) should not be used after the expiration (EXP) date printed on the carton and the label.
SYMLIN pen-injectors in use: After first use, refrigerate or keep at a temperature not greater than 86°F (30°C) for 30 days. Use within 30 days, whether or not refrigerated.
Storage conditions are summarized in Table 9.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Risk of Hypoglycemia
Discuss the risk and consequences of hypoglycemia and approaches to minimize its occurrence. Inform patients about the importance of self-management practices including glucose monitoring and timing of dosing. In addition, reinforce the importance of adherence to meal planning, physical activity, recognition and management of hypoglycemia and hyperglycemia, and assessment of diabetes complications.
Never Share a SymlinPen Between Patients
Advise patients that they must never share a SymlinPen with another person, even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens.
Never Mix SYMLIN and Insulin
Inform patients that SYMLIN and insulin should always be administered as separate injections and never be mixed.
Show patients how to administer SYMLIN using the pen-injector. Advise patients to use a new needle for each injection.
Instructions
Instruct patients on the proper injection technique and proper storage of SYMLIN. Refer patients to the SYMLIN Medication Guide and Patient Instructions for Use for additional information.
Distributed by:
AstraZeneca Pharmaceuticals LP
SYMLIN and SymlinPen are registered trademarks of the AstraZeneca group of companies.
10MEDICATION GUIDE
SYMLIN (SĬM-lĭn)
(pramlintide acetate)
(pramlintide acetate)
injection for subcutaneous use
Read this Medication Guide and Instructions for Use that come with your SYMLIN before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about SYMLIN?
SYMLIN can cause serious side effects, including:
- severe low blood sugar (hypoglycemia). Even when SYMLIN is carefully added to your mealtime insulin therapy, your blood sugar may drop too low, especially if you have type 1 diabetes. If this severe low blood sugar (hypoglycemia) happens, it is seen within 3 hours after a SYMLIN injection. Symptoms of severe low blood sugar and low blood sugar include:
- lightheadedness
- dizziness
- shakiness
- sweating
- hunger
- fast heartbeat
- trouble concentrating or confusion
- change in vision
- headache
- irritability
- drowsiness
People who have severely low blood sugar have had injuries while driving their car, operating heavy machinery or doing other dangerous activities. You and your healthcare provider should talk about a plan to treat low blood sugar. You should have fast-acting sugar (such as hard candy, glucose tablets, juice) or glucagon for injection with you at all times. Call your healthcare provider if you have severe low blood sugar or if you have low blood sugar more often than normal.
- You have a higher chance of getting severe low blood sugar if you:
- do not follow your healthcare provider’s instructions to reduce your insulin use before meals
- use more SYMLIN or insulin than prescribed by your healthcare provider
- change your insulin dose without checking your blood sugar
- eat less food than your usual meal
- are sick and cannot eat
- are more active than usual
- have a low blood sugar level before eating
- drink alcohol
- SYMLIN is used with insulin to lower blood sugar, especially high blood sugar that happens after meals.
- SYMLIN is taken at mealtimes. The use of SYMLIN does not replace your daily insulin but may lower the amount of insulin you need, especially before meals.
Do not share your SymlinPen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
What is SYMLIN?
SYMLIN is an injectable prescription medicine used to treat adults with type 1 and type 2 diabetes to control blood sugar. SYMLIN is used when your mealtime insulin dose has not controlled your blood sugar well enough.
It is not known if SYMLIN is safe and effective in children.
Who should not use SYMLIN?
Do not use SYMLIN if you:
- are allergic to SYMLIN or any ingredients in SYMLIN. See the end of this Medication Guide for a complete list of ingredients in SYMLIN.
- cannot tell when your blood sugar is low (hypoglycemia unawareness)
- have a stomach problem called gastroparesis. This is when your stomach does not empty as fast as it should.
What should I tell my healthcare provider before using SYMLIN?
Before you use SYMLIN, tell your healthcare provider about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant. It is not known if SYMLIN will harm your unborn baby. You and your healthcare provider should decide how to best control your blood sugar levels during pregnancy.
- are breastfeeding or plan to breastfeed. It is not known if SYMLIN passes into your breast milk. You and your healthcare provider should decide about the best way to feed your baby if you are using SYMLIN.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SYMLIN slows stomach emptying and can affect medicines that need to pass through the stomach quickly.
How should I use SYMLIN?
- Read the “Instructions for Use” and the Medication Guide and that come with your SYMLIN for information about the right way to use SYMLIN.
- Use SYMLIN exactly as your healthcare provider tells you to use it.
- Your healthcare provider will tell you how much SYMLIN to use and when to use it.
- Your healthcare provider may change your dose if needed.
- If you stop taking SYMLIN for any reason, such as surgery or illness, talk to your healthcare provider about how to re-start SYMLIN.
- To reduce the risk of hypoglycemia, it is important that you plan your meals and physical activity every day while you use SYMLIN. Plan for what you will eat and when you will eat your meals.
- The amount of SYMLIN you use will depend on whether you have type 1 or type 2 diabetes.
- The way you inject SYMLIN is similar to the way you inject insulin. Inject SYMLIN under the skin of your stomach area (abdomen) or upper leg (thigh). Inject SYMLIN at a site that is more than 2 inches away from your insulin injection. Do not inject SYMLIN and insulin in the same site.
- To help reduce the chances of getting a reaction at the injection site, allow SYMLIN to come to room temperature before injecting.
- Use a new needle for each SYMLIN injection.
- Never mix SYMLIN and insulin. Insulin can affect SYMLIN when they are mixed together.
- Do not use SYMLIN if the liquid looks cloudy.
- If you take more than your prescribed dose of SYMLIN, you may get nauseous or vomit, and may not be able to eat the amount of food you usually eat. If you take more SYMLIN than your prescribed dose, pay careful attention to the amount of insulin you use because you may be at more risk for low blood sugar. Contact your healthcare provider for guidance.
- If you miss or forget a dose of SYMLIN, wait until the next meal and take your usual dose of SYMLIN at that meal.
- Do not share your SymlinPen with other people, even if the needle is changed.You may give other people a serious infection or get a serious infection from them.
Using SYMLIN and insulin with type 1 diabetes:
- When starting SYMLIN, you will need to reduce your dose of mealtime insulin. Your healthcare provider will tell you how to reduce your dose of mealtime insulin the right way.
- You must check your blood sugar as often as your healthcare provider tells you to, which may include before and after every meal and at bedtime.
- The usual starting dose of SYMLIN for people who have type 1 diabetes is 15 micrograms (mcg) injected under your skin.
- Inject SYMLIN under your skin (subcutaneously) just before a major meal. A major meal must have at least 250 calories or 30 grams of carbohydrate.
- If you have not had any nausea for 3 days or more after your dose of SYMLIN is changed, your healthcare provider may tell you to slowly increase your dose of SYMLIN.
- Tell your healthcare provider right away if you have nausea or low blood sugar after your dose of SYMLIN is changed. Your healthcare provider will tell you what to do.
- Your healthcare provider may make changes to your insulin dose to better control your blood sugar. Your healthcare provider should tell you what the right dose of insulin is for you.
Using SYMLIN and insulin with type 2 diabetes:
- When starting SYMLIN, you will need to reduce your dose of mealtime insulin. Your healthcare provider will tell you how to reduce your dose of mealtime insulin the right way.
- You must check your blood sugar as often as your healthcare provider advises you to, which may include before and after every meal and at bedtime.
- The usual starting dose of SYMLIN for people who have type 2 diabetes is 60 micrograms (mcg) injected under your skin.
- Inject SYMLIN under your skin (subcutaneously) just before a major meal. A major meal must have at least 250 calories or 30 grams of carbohydrate.
- If you have not had any nausea for 3 days or more after your dose of SYMLIN is changed, your healthcare provider may tell you to increase your dose of SYMLIN.
- Tell your healthcare provider right away if you have nausea or low blood sugar after your dose of SYMLIN is changed. Your healthcare provider will tell you what to do.
- Your healthcare provider may make changes to your insulin dose to better control your blood sugar. Your healthcare provider should tell you what the right dose of insulin is for you.
What should I avoid while taking SYMLIN?
- See “What is the most important information I should know about SYMLIN?”
- Do not drive, operate machinery, or do other dangerous activities until you know how SYMLIN affects you. Talk to your healthcare provider about the activities you should avoid.
- Alcohol. Drinking alcohol may increase your chances of getting severe low blood sugar.
What are the possible side effects of SYMLIN?
SYMLIN may cause serious side effects, including:
- See “What is the most important information I should know about SYMLIN?”
- injection site reactions. SYMLIN may cause bruising, swelling, or itching at the injection site.
The most common side effects of SYMLIN include:
- nausea
- vomiting
- decreased appetite
- stomach pain
- headache
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of SYMLIN. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store SYMLIN?
Unopened SYMLIN:
- Keep SYMLIN in the refrigerator between 36°F to 46°F (2°C to 8°C), until you are ready to use it.
- Do not freeze. Do not use SYMLIN if it has been frozen.
- Keep unopened SYMLIN out of the light.
Opened SYMLIN:
- Keep SYMLIN either in the refrigerator or at room temperature between 36°F to 86°F (2°C to 30°C) for up to 30 days.
- Throw away used SYMLIN after 30 days of use, even if the pen still has medicine in it.
- Do not use SYMLIN (opened or unopened) after the expiration (EXP) date printed on the carton and the label.
Keep SYMLIN and all medicines out of the reach of children.
General information about the safe and effective use of SYMLIN:
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SYMLIN for a condition for which it was not prescribed. Do not give SYMLIN to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about SYMLIN. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about SYMLIN that is written for health professionals.
More information, go to www.SYMLIN.com or call 1-800-236-9933.
What are the ingredients in SYMLIN?
Active ingredient: pramlintide acetate
Inactive ingredients: metacresol, D-mannitol, acetic acid, and sodium acetate
This Medication Guide has been approved by the U.S. Food and Drug Administration.
SYMLIN and SymlinPen are registered trademarks of the AstraZeneca group of companies.
Distributed by:
AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
Revised: February 2015
11PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1.5 mL pen-injector
SymlinPen
(pramlintide acetate)
pen-injector
For Single Patient Use Only
For doses of 15 mcg, 30 mcg, 45 mcg, and 60 mcg.
Two disposable multidose pen-injectors pramlintide acetate 1000 mcg/mL, 1.5 mL
Subcutaneous use only. Pen needles not included. Use 29, 30, or 31 gauge disposable pen needles. Ask your healthcare provider which needle gauge and length is best for you.
Rx Only AstraZeneca
12PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 2.7 mL pen-injector
SymlinPen
(pramlintide acetate)
pen-injector
Two 2.7 mL disposable multidose pen-injectors 60•120 mcg NDC 0310-6627-02
For Single Patient Use Only
For doses of 60 mcg and 120 mcg.
Two disposable multidose pen-injectors pramlintide acetate 1000 mcg/mL, 2.7 mL
Subcutaneous use only. Pen needles not included. Use 29, 30, or 31 gauge disposable pen needles. Ask your healthcare provider which needle gauge and length is best for you.
Rx Only AstraZeneca