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Symlin Classification Essay

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Symlin classification essay

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Other articles

Clinical trial: A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus

Condition(s) targeted: Type 1 Diabetes Mellitus

Intervention: pramlintide acetate (Drug)

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Lisa Porter, MD, Study Director, Affiliation: Amylin Pharmaceuticals, LLC.

This study will be the first evaluation of Symlin in adolescent subjects with type 1 diabetes mellitus and is designed to evaluate the blood levels (pharmacokinetics), biochemical and physiological effects (pharmacodynamics), and safety and tolerability of Symlin in these subjects.

Official title: A Randomized, Single-Blind, Dose-Rising, Placebo-Controlled, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of SYMLIN in Adolescent Subjects With Type 1 Diabetes Mellitus

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: To evaluate the pharmacokinetics of Symlin in adolescent subjects with type 1 diabetes

To assess the safety and tolerability of Symlin in adolescent subjects with type 1 diabetes

Secondary outcome: To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria: Inclusion Criteria:

- Diagnosed with type 1 diabetes mellitus for at least 1 year prior to screening

- Be on a stable regimen requiring multiple daily injections of basal and mealtime

insulin or continuous subcutaneous insulin infusion for at least 2 weeks prior to screening

- HbA1c between 6. 0% and 10. 0%, inclusive, at screening

- Body weight >=50 kg at screening

- Currently being treated with the following medications: *Any oral antihyperglycemic

agent; *Drugs that directly affect gastrointestinal motility

- Has been previously treated with Symlin/pramlintide (or has participated in a

Symlin/pramlintide clinical study)

- Has received any investigational drug within 1 month of screening

Locations and Contacts

Research Site, Aurora, Colorado, United States

Research Site, Kansas City, Missouri, United States

Research Site, New York, New York, United States Additional Information

Starting date: April 2006
Last updated: March 5, 2015

Page last updated: August 23, 2015

Common Side Effects of Symlin (Pramlintide Acetate Injection) Drug Center

Last reviewed on RxList 8 /8/2016

Symlin (pramlintide acetate) Injection is an antihyperglycemic drug used together with insulin to treat type 1 or type 2 diabetes. Common side effects of Symlin include:

  • nausea
  • vomiting
  • loss of appetite
  • tiredness
  • stomach pain or upset as your body adjusts to the medication

Other side effects of Symlin include:

  • runny or stuffy nose
  • sore throat
  • cough
  • headache
  • joint pain
  • injection site reactions that last a few days (redness, swelling, and itching)

The dose of Symlin depends on the type of diabetes being treated. Symlin may interact with acarbose, miglitol, atropine. belladonna. benztropine, dimenhydrinate, methscopolamine, scopolamine. bronchodilators, glycopyrrolate, mepenzolate, bladder or urinary medications, or irritable bowel medications. Medicines that can make it harder for you to tell when you have low blood sugar include albuterol, clonidine, cholesterol -lowering medications, or ACE inhibitors. Hyperglycemia (high blood sugar ) may result if Symlin is taken with isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicine, birth control pills and other hormones, seizure medicines, diet pills or medicines to treat asthma. colds or allergies. Hypoglycemia (low blood sugar) may result if Symlin is taken with probenecid, nonsteroidal anti-inflammatory drugs (NSAIDs ), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), or beta-blockers. Tell your doctor all medications and supplements you use. During pregnancy, Symlin should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Symlin (pramlintide acetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Symlin in Detail - Patient Information: Side Effects

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;
  • nausea, loss of appetite;
  • headache, 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 Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Symlin Overview - Patient Information: Side Effects

SIDE EFFECTS: Consult your pharmacist.

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.

Read the entire patient information overview for Symlin (Pramlintide Acetate Injection)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Symlin FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS

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.

Clinical Trial Experience Adverse Reactions (Excluding Hypoglycemia)

Adverse reactions (excluding hypoglycemia. which is discussed separately below) commonly associated with SYMLIN when coadministered with a fixed dose of insulin in the 26-to 52-week, placebo-controlled trials in patients with type 1 diabetes and patients with type 2 diabetes on mealtime insulin are presented in Table 1 and Table 2, respectively.

Table 1: Patients with Type 1 Diabetes: Common Adverse Reactions (Incidence ≥ 5% and Greater Incidence with SYMLIN Compared to Placebo) in 3 Pooled Placebo-Controlled Trials

Long-Term, Placebo-Controlled Studies

SYMLIN 30 or 60 mcg 3 Times Daily + Insulin
(N=716) %

Most adverse reactions were gastrointestinal in nature. The incidence of nausea is higher at the beginning of SYMLIN treatment and decreases with time in most patients. Gradual titration of the SYMLIN dose minimizes the incidence and severity of nausea [see DOSAGE AND ADMINISTRATION ].

Severe Hypoglycemia

Coadministration of SYMLIN with mealtime insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes [see BOXED WARNING and WARNINGS AND PRECAUTIONS ].

Two definitions of severe hypoglycemia were used in the SYMLIN clinical trials. Patient-ascertained severe hypoglycemia was defined as an episode of hypoglycemia requiring the assistance of another individual (including help administering oral carbohydrate ) or requiring the administration of glucagon, intravenous glucose, or other medical intervention. Medically-assisted severe hypoglycemia was defined as an episode of hypoglycemia that was classified as a serious event by the investigator or that required glucagon, intravenous glucose, hospitalization, paramedic assistance or an emergency room visit. The incidence of severe hypoglycemia during the SYMLIN clinical development program is summarized in Table 3 and Table 4.

Table 3: Incidence and Event Rate of Severe Hypoglycemia in Six-Month, Placebo-Controlled Trials and Dose Titration Trial in Patients with Type 1 Diabetes

Long-Term, Placebo-Controlled Studies (No Insulin Dose-Reduction During Initiation)

Placebo-Controlled Dose Titration Study

1 Patient-ascertained severe hypoglycemia: Requiring the assistance of another individual (including help ingesting oral carbohydrate) and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.
2 Medically-assisted severe hypoglycemia: Requiring glucagon, intravenous glucose, hospitalization, paramedic assistance, emergency room visit, and/or assessed as a serious adverse event by the investigator.

Table 4: Incidence and Event Rate of Severe Hypoglycemia in Six-Month, Placebo-Controlled Trials in Patients with Type 2 Diabetes Using Insulin

Long-Term, Placebo-Controlled Studies (No Insulin Dose-Reduction During Initiation)

0 to 3 Months
(n=292)

> 3 to 6 Months
(n=255)

0 to 3 Months
(n=284)

> 3 to 6 Months
(n=251)

Event Rate (events/patient-year)

Event Rate (events/patient-year)

1 Patient-ascertained severe hypoglycemia: Requiring the assistance of another individual (including help ingesting oral carbohydrate) and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.
2 Medically-assisted severe hypoglycemia: Requiring glucagon, intravenous glucose, hospitalization, paramedic assistance, emergency room visit, and/or assessed as a serious adverse event by the investigator.

Postmarketing 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.

Read the entire FDA prescribing information for Symlin (Pramlintide Acetate Injection)

Related Resources for Symlin Related Health Related Drugs

© Symlin Patient Information is supplied by Cerner Multum, Inc. and Symlin Consumer information is supplied by First Databank, Inc. used under license and subject to their respective copyrights.

Symlin classification essay

Pharmacologic class: Synthetic amylin

Therapeutic class: Hypoglycemic

Pregnancy risk category C

FDA Box Warning

• Drug is used with insulin and has been linked to increased risk of insulin-induced severe hypoglycemia, especially in patients with type 1 diabetes. When severe hypoglycemia occurs, it arises within 3 hours after injection. If it occurs while patient operates a motor vehicle or heavy machinery or performs other high-risk activities, serious injuries may occur. Careful patient selection, patient instruction, and insulin dosage adjustments are crucial to reduce risk.

Mimics amylin activity to modulate gastric emptying, prevent postprandial rise in plasma glucagons, and cause feeling of satiety leading to decreased caloric intake and potential weight loss

Availability

Solution for injection: 0.6 mg/ml in 5-ml vials; 1.5-ml disposable multidose pen-injector containing 1,000 mcg/ml; 2.7-ml disposable multidose 120 pen-injector containing 1,000 mcg/ml

Indications and dosages

➣ Type 1 diabetes mellitus as adjunct treatment in patients who take insulin with meals but haven't obtained desired glycemic control despite optimal insulin therapy

Adults: Initially, 15 mcg subcutaneous injection immediately before major meals; after 3 days, increase in 15-mcg increments to maintenance dosage of 30 or 60 mcg as tolerated. Decrease preprandial rapid- or short-acting insulin dosages (including fixed-mix insulins) by 50%.

➣ Type 2 diabetes mellitus as adjunct treatment in patients who take insulin with meals but haven't obtained desired glycemic control despite optimal insulin therapy, with or without concurrent sulfonylurea, metformin, or both

Adults: Initially, 60 mcg subcutaneous injection immediately before major meals; after 3 to 7 days, increase to 120 mcg as tolerated. Decrease preprandial rapid- or short-acting insulin dosages (including fixed-mix insulins) by 50%.

Contraindications

• Hypersensitivity to drug or its components
• Confirmed gastroparesis
• Hypoglycemia unawareness

Precautions

Use cautiously in:
• patients with poor compliance to insulin therapy or hemoglobin A1c levels above 9%
• patients with recurrent or severe hypoglycemia who've required treatment during past 6 months
• concurrent insulin therapy for type 1 diabetes
• concurrent use of drugs that stimulate GI motility
• elderly patients
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Administer immediately before major meals (at least 250 kcal or 30 g carbohydrates).
• Give pramlintide and insulin as separate injections.
• Inject pramlintide and insulin more than 2" apart.

Adverse reactions

CNS: headache, dizziness, fatigue

GI: nausea, vomiting, abdominal pain, anorexia

Metabolic: severe hypoglycemia

Other: allergic reaction

Interactions

Drug-drug.Angiotensin-converting enzyme inhibitors, disopyramide, fibric acid derivatives, fluoxetine, monoamine oxidase inhibitors, oral hypoglycemics, pentoxifylline, propoxyphene, salicylates, sulfonamide antibiotics: increased hypoglycemic effect, increased risk of hypoglycemia

Beta-adrenergic blockers, clonidine, guanethidine, reserpine: blunting of early hypoglycemia symptoms

Drugs that delay gastric emptying (such as atropine) or slow food absorption (such as acarbose): exacerbated delay in gastric emptying, slow food absorption

Insulin: severe hypoglycemia (may occur within 3 hours of insulin administration)

Oral drugs for which rapid effect is desired (such as analgesics): delayed absorption of these drugs

Patient monitoring

• Monitor premeal and postmeal blood glucose levels closely; watch for hypoglycemia.

Patient teaching

• Instruct patient to take drug immediately before major meals.
• Teach patient how to self-administer injection; describe proper storage, handling, and disposal of drug and supplies.
• Instruct patient to inject pramlintide and insulin separately, more than 2" apart. Caution patient not to mix them together.

☞ Teach patient to recognize and immediately report hypoglycemia symptoms; tell him these may occur within 3 hours after pramlintide injection.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.

pramlintide Classification

Therapeutic: antidiabetics
Pharmacologic: hormones

Pregnancy Category:
  • C

    Indications

    Used with mealtime insulin in the management of diabetics whose blood sugar cannot be controlled by optimal insulin therapy; can be used with other agents (sulfonylureas, metformin).

    Acts as a synthetic analogue of amylin, an endogenous pancreatic hormone that helps to control postprandial hyperglycemia; effects include slowed gastric emptying, suppression of glucagon secretion and regulation of food intake.

    Therapeutic effects

    Improved control of postprandial hyperglycemia.

    Pharmacokinetics

    Absorption: 30–40% absorbed following subcutaneous administration.

    Distribution: Does not appear to significantly cross the placenta.

    Metabolism and Excretion: Metabolized by the kidneys; major metabolite has pharmacologic properties similar to the parent compound.

    Half-life: 48 min.

    Time/action profile (effect on blood sugar*) Dermatologic Musculoskeletal Miscellaneous
    • injection site reactions
    • systemic allergic reactions
    Interactions Drug-Drug interaction

    ↑ likelihood of hypoglycemia with short-acting insulin ; ↓ dose of short-acting pre-meal insulin by 50%.Avoid concurrent use with other agents that ↓ GI motility, including atropine and other anticholinergics .Avoid concurrent use with other agents that ↓ GI absorption of nutrients, including α-glucosidase inhibitors including acarbose and miglitol .May delay oral absorption of concurrently administered drugs; if prompt absorption is desired, administer 1 hr before or 2 hr after pramlintide.

    Route/Dosage Insulin-using Type 2 Diabetes

    Subcutaneous(Adults) 60 mcg, immediately prior to major meals initially, if no significant nausea occurs, dose may be ↑ to 120 mcg.

    Type 1 Diabetes

    Subcutaneous(Adults) 15 mcg, immediately prior to major meals initially, if no significant nausea occurs, dose may be ↑ by 15 mcg every 3 days up to 60 mcg.

    Availability

    Pen-injector: 1000 mcg/mL

    Solution for injection: 600 mcg/mL

    Nursing implications Nursing assessment
    • Assess hemoglobin A1c, recent blood glucose monitoring data, history of insulin-induced hypoglycemia, current insulin regimen, and body weight prior to initiation of therapy.
    • Assess for signs and symptoms of hypoglycemia (hunger, headache, sweating, tremor, irritability, difficulty concentrating, loss of consciousness, coma, seizure), occurs within 3 hr of injection. Pramlintide alone does not cause hypoglycemia, may increase risk when administered with insulin.
    • Lab Test Considerations: Monitor blood glucose frequently, including pre- and post-meals and at bedtime.
    Potential Nursing Diagnoses

    Noncompliance (Patient/Family Teaching)

    Implementation
    • high alert: Dose errors are a potential problem with administration of pramlintide. Pramlintide is available in a concentration of 0.6 mg/mL, dosing is in mcg, and insulin syringe for administration is in units. Carefully review dosing and conversion table prior to administration.
    • Administer pramlintide and insulin as separate injections; do not mix.
      • Adjust insulin doses to optimize glycemic control once target dose of pramlintide is achieved and nausea has subsided.
    • Subcutaneous: Administer immediately prior to major meals ≥250 kcal or containing ≥30 g of carbohydrate. Reduce preprandial rapid-acting, short-acting, and fixed-mix insulin doses by 50%. Use a U-100 syringe (preferably a 0.3 mL size) for optimal accuracy. Administer into abdomen or thigh, rotating injection sites. Do not administer solutions that are cloudy. Store unopened vials in refrigerator. Opened vials may be refrigerated or kept at room temperature for up to 28 days.
    Patient/Family Teaching
    • Instruct patient in proper use of pramlintide (injection technique, timing of doses, storage, and disposal of equipment). Make sure patient understands dosing and preparation of correct dose. Emphasize importance of adherence to meal planning, physical activity, recognition and management of hypoglycemia and hyperglycemia, and assessment of diabetes complications. Advise patient to read the Medication Guide before use and with each refill for new information.
    • Review with patient how to handle illness or stress, inadequate or omitted insulin dose, inadvertent administration of increased dose of insulin or pramlintide, inadequate food intake or missed meals. If a dose is missed, wait until the next meal and take usual dose; do not give an additional injection.
    • Instruct patient to contact health care professional at least once a week until target dose of pramlintide is achieved, pramlintide is well-tolerated, and blood glucose concentrations are stable.
    • May cause difficulty concentrating. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
    • Inform patient that signs of local allergy (redness, swelling, itching at site of injection) usually resolve within a few days to a few weeks; may be related to pramlintide, irritants in skin cleansing agent or improper injection technique.
    • Advise patient to contact health care professional if recurrent nausea or hypoglycemia occur; may lead to increased risk of severe hypoglycemia. Discontinue pramlintide therapy if recurrent unexplained hypoglycemia requiring medical assistance, persistent clinically significant nausea, or noncompliance with self-monitoring of blood glucose concentrations, insulin dose adjustments, or scheduled health care professional contacts or recommended clinic visits occur.
    • Advise patient to contact health care professional before taking other Rx, OTC, vitamins, or herbal products with pramlintide and to avoid concurrent alcohol use.
    • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding.
    Evaluation/Desired Outcomes
    • Reduction in postprandial glucose concentrations.

    Comment: Symlin is a synthetic analog of human amylin, a neuroendocrine hormone produced by pancreatic [beta]-cells that contribute to postprandial glucose control.

    Analysis and review of Symlin including historical sales data

    The Position Statement included key clinical considerations for the use of SYMLIN. reaffirming its use in conjunction with mealtime insulin to decrease post-meal glucose excursions.

    The findings from this analysis help us better understand the therapeutic benefit of SYMLIN as an adjunct therapy for patients with type 1 diabetes who use insulin pumps, as evidenced by reductions in A1C, insulin requirements (especially mealtime insulin) and weight.

    Multiple presentations at this year's meeting demonstrate the durability of effect and long-term safety and tolerability of BYDUREON and BYETTA, as well as provide important insights into the effect of SYMLIN on glucose targets," said Daniel M.

    The data presented will demonstrate significant progress and new insights concerning the scientific basis and clinical utility of BYETTA, BYDUREON and SYMLIN .

    Both Byetta and Symlin revenues declined on a sequential as well as year-over-year basis.

    Use of physician level data for SYMLIN is critical in meeting the Food and Drug Administration's risk mitigation requirement.

    SYMLIN is a drug for patients with type 2 or type 1 diabetes who use mealtime insulin.

    Expand the use of BYETTA (exenatide) injection, and develop the value of SYMLIN (pramlintide acetate) injection;

    Nasdaq: AMLN) today announced results from an analysis of an integrated database of clinical studies that showed no increased risk of cardiovascular (CV) events associated with SYMLIN (pramlintide acetate) injection use compared to a pooled comparator group treated with either placebo or rapid-acting insulin.

    Nasdaq: AMLN) today announced that the Company will present data for its FDA-approved diabetes drugs, BYETTA (exenatide) injection and SYMLIN (pramlintide acetate) injection, and its investigational diabetes drug candidate BYDUREON(TM) (exenatide extended-release for injectable suspension) at the American Diabetes Association's (ADA's) 70th Annual Scientific Sessions being held in Orlando, FL from June 25 to June 29.