SymlinPen

In the U.S.

• Symlin
• SymlinPen

Available Dosage Forms:

• Solution

Therapeutic Class: Antidiabetic

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of pramlintide injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pramlintide injection in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Balofloxacin
• Besifloxacin
• Ciprofloxacin
• Enoxacin
• Fleroxacin
• Flumequine
• Gatifloxacin
• Gemifloxacin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Lanreotide
• Levofloxacin
• Lomefloxacin
• Moxifloxacin
• Nadifloxacin
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Pazufloxacin
• Pefloxacin
• Prulifloxacin
• Rufloxacin
• Sparfloxacin
• Thioctic Acid
• Tosufloxacin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Atenolol
• Betaxolol
• Bisoprolol
• Carteolol
• Carvedilol
• Celiprolol
• Esmolol
• Labetalol
• Levobunolol
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Penbutolol
• Pindolol
• Practolol
• Propranolol
• Sotalol
• Timolol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Gastroparesis (stomach does not empty food normally) or
• High HbA1c level, greater than 9% (lab test used for diabetics) or
• Hypoglycemia (severe), occurs often and required doctor's help in the past 6 months or
• Hypoglycemia unawareness (not able to recognize low blood sugar symptoms)—Should not be used in patients with these conditions.

• Hypoglycemia from insulin, history of—May increase risk of severe hypoglycemia occurring again.

• Infection or
• Stress (eg, physical or emotional)—May increase the amount of pramlintide that is needed.

It is very important that your doctor check your progress at regular visits, especially during the first few weeks you receive this medicine. Blood tests may be needed to see how well you have adjusted to the medicine.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol (including beer and wine) may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes, especially teenagers, may need special counseling about pramlintide dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in women with diabetes who become pregnant.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times, and store pramlintide properly.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

• Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and lists all of your medicines.
• Keep an extra supply of insulin and syringes with needles on hand in case high blood sugar occurs.
• Keep some kind of quick-acting sugar handy to treat low blood sugar.
• Have a glucagon kit available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

When used together with insulin, pramlintide may cause hypoglycemia (low blood sugar), especially in patients with type 1 diabetes. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.

Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family should also know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), ketones in the urine, loss of appetite, stomachache, nausea or vomiting, tiredness, troubled breathing (rapid and deep), unconsciousness, or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

You may have some skin redness, swelling, or itching at the injection site. If this irritation is severe or does not go away, call your doctor.

Applies to pramlintide: subcutaneous solution

Along with its needed effects, pramlintide (the active ingredient contained in Symlin Pen) 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

Applies to pramlintide: subcutaneous solution

Metabolic

Very common (10% or more): Severe hypoglycemia (up to 16.8%), anorexia (up to 17%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 48%), vomiting (up to 11%)
Common (1% to 10%): Abdominal pain
Frequency not reported: Slower gastric emptying
Postmarketing reports: Pancreatitis[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reaction[Ref]

Nervous system

Very common (10% or more): Headache
Common (1% to 10%): Dizziness[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia[Ref]

Respiratory

Common (1% to 10%): Cough, pharyngitis[Ref]

General

The most commonly reported side effects were: nausea, vomiting, and severe hypoglycemia.[Ref]

Local

Postmarketing reports: Injection site reactions[Ref]

Other

Very common (10% or more): Inflicted injury (14%)
Common (1% to 10%): Fatigue[Ref]

Some side effects of Symlin Pen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.