pramlintide mechanism of action
The risk or severity of hypoglycemia can be increased when Acarbose is combined with Pramlintide. noncompliance with insulin dose adjustments. General information about the safe and effective use of
Your healthcare provider will tell you how to reduce your
Change (rotate) injection sites for SYMLIN. and at bedtime. Manufacturer: Bristol Myers-Squibb This prevents blood sugar from growing too excessive after a meal. The therapeutic efficacy of Pramlintide can be increased when used in combination with Acetazolamide. risk for transmission of blood-borne pathogens. when SYMLIN is mixed in the same syringe with regular, NPH, and 70/30 premixed
Amylin reduces the production of glucose by the liver by inhibiting the action of glucagon, a hormone produced by the pancreas that stimulates the production of glucose by the liver. voluntarily from a population of uncertain size, it is not always possible to reliably
separate injections. You should see the number 60 in the window. SYMLIN should be used during pregnancy only if
straight onto the end of the SymlinPen. overdose. healthcare provider tells you to. in congenital abnormalities (neural tube defect, cleft palate, exencephaly)
SYMLIN was initiated at a dose of 15 mcg and titrated upward
SymlinPen for the first time. during post-approval use of SYMLIN. to the amount of insulin you use because you may be at more risk for low blood
require the use of drugs that stimulate gastrointestinal
30-59 mL/min) or severe renal impairment (ClCr 15-29 mL/min). will need to follow your community guidelines for the right way to dispose of
plan to eat a meal with less than 250 calories or 30
Once the knob has been pulled out, the dial will not move
A single, subcutaneous dose of 30 mcg of SYMLIN to
all the way, and you cannot turn the dial, call Information Support. Pramlintide belongs to a class of medicines called antihyperglycemics. who have failed to achieve desired glucose control despite optimal insulin therapy. technique. lumps or particles in it. Diabetes Using Insulin. post-meals and at bedtime, particularly when initiating SYMLIN or increasing
The use of SYMLIN
Months in the Double-Blind, Placebo-Controlled Studies in Patients with Type 1
Included as part of the PRECAUTIONS section. Coadministration of SYMLIN with mealtime insulin
Pramlintide is an amlyinomimetic, a functional analog of the naturally occurring pancreatic hormone amylin. It slows the rate that food moves from your stomach to … in Table 3 and Table 4. of both products which may result in inadequate glucose control or
The risk or severity of hypoglycemia can be increased when Pramlintide is combined with Liraglutide. grams of carbohydrate, are having surgery or a medical test where you cannot eat. The incidence of nausea is higher at the beginning of SYMLIN treatment and
Because these reactions are reported
TZDs exert their antidiabetic effects through a mechanism that involves activation of the gamma iso … SYMLIN therapy should be discontinued if there is: SYMLIN should be inspected visually for particulate
Pramlintide is in a class of medications called antihyperglycemics. to the infant. Pramlintide is a synthetic analog of amylin, a glucoregulatory hormone that is synthesized by pancreatic β-cells and released into the bloodstream, in a similar pattern as insulin, after a meal. Pen
either SYMLIN or placebo, both administered before major meals as add-on to
self-management practices including glucose monitoring and timing of dosing. analogs were used, plasma glucose concentrations tended to rise during the
SYMLIN has a pH of approximately 4.0. Pramlintide is metabolized primarily by the kidneys. pancreatic beta cells in response to food intake. sizes: SymlinPen® 60 pen-injector, containing 1000 mcg/mL
[, Lutz TA: The role of amylin in the control of energy homeostasis. be rotated so that the same site is not used repeatedly. following dosage forms: SYMLIN Injection is available in the following package
If severe hypoglycemia associated with SYMLIN
or less pronounced under certain conditions, such as longstanding diabetes;
Upon initiation of SYMLIN, the
Refrigerate (2°C to 8°C; 36°F to 46°F), and protect from
sulfonylurea), or other medications that can increase the risk of hypoglycemia
Pramlintide is only used to treat patients whose blood sugar could not be controlled by insulin or insulin and an oral medication for diabetes. variability (% CV for AUC: 73%-106%), compared with exposure after injection of
should only be considered in patients with type 1 diabetes or patients with
your household trash unless your community guidelines permit this. getting severe low blood sugar. Table 1: Patients with Type 1 Diabetes: Common Adverse
The incidence
in pediatric patients due to the risk of severe hypoglycemia [see WARNINGS
By mimicking amylin, pramlintide slows gastric emptying, inhibits digestive secretions (gastric acid, pancreatic enzymes, and bile), reduces glucagon secretion, and increases satiety; all of these actions are mediated mostly by glucose -sensitive areas in the brain stem. inject. The time to maximum plasma concentration or Tmax increased by 72, 48,
When the rapid onset or threshold
Therefore, when introducing SYMLIN therapy, appropriate
was 32.9 kg/m² for SYMLIN and 32.2 kg/m² for placebo. Medically-assisted severe hypoglycemia
Am Fam Physician. assigned to the 30 or 60 mcg dose of SYMLIN or placebo. food intake. which it was not prescribed. When your sharps disposal container is almost full, you
SYMLIN is formulated as a clear, isotonic, sterile solution for subcutaneous administration. Tell your healthcare provider right away if you have
This prevents blood sugar from growing too excessive after a meal. Pramlintide also lowers the amount of glucose (sugar) your liver produces. the label. These compounds are orally active and have been shown to be …. SYMLIN or placebo was added to existing insulin therapies. Mechanism of action of inhibitors of dipeptidyl-peptidase-4 (DPP-4) Dipeptidyl-peptidase IV (DPP-4) inhibitors inhibit the degradation of the incretins, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). You should see the number 15 in the window. While SYMLIN reduces postprandial glucose, clinical
Amylin is
Read the Medication Guide and these Instructions for Use
If correct dose was not selected, push in the knob
recommended dose of 120 mcg for patients with type 2 diabetes) were
injection. 2006 Oct;5(10):821-34. Keep SYMLIN in the refrigerator between 36°F to 46°F (2°C
for Use for additional information. It may decrease appetite and cause weight loss. Do not use SYMLIN if the liquid looks cloudy or colored or has
knob all the way in until it stops. mean reductions of -1.4 kg, and -1.6 kg in the SYMLIN treatment group
should throw away used needles and SymlinPen. For the treatment of type 1 and type 2 diabetes mellitus as an adjunct to preprandial insulin therapy in patients without adequate glycemic control of insulin therapy. After first use, refrigerate or keep at a temperature not
normalized by insulin alone), which leads to suppression of endogenous glucose
effective use of SYMLIN. Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Use a new needle for each SYMLIN injection. It is unknown whether SYMLIN is excreted in human milk. significantly different between obese and non-obese patients and based on BMI
2008 Oct;74(4):1059-71. doi: 10.1124/mol.108.047142. If the knob is pushed in all
surgery or illnesses), the same initiation protocol should be followed when
children. insulin dose (mostly the mealtime insulin) was reduced by 30% to 50% in order
Injection sites should
of severe hypoglycemia during the SYMLIN clinical development program is summarized
It is not known if SYMLIN is safe and effective in
SYMLIN into the abdominal area or thigh. WARNING: SEVERE HYPOGLYCEMIASYMLIN use with insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes. should hear a “clicking” sound while you are pulling the knob out. If you drop your SymlinPen, you should prime it before
assessment of diabetes complications. container, you may use a household container that is: can be closed with a tight-fitting, puncture-resistant
titrating SYMLIN to the next dose increment. Patients participating in these 2 trials had a mean age
Insulin doses were to be kept as
SYMLIN. will not affect your dose. its product components. should be administered to nursing women only if it is determined by the
For more information, ask your healthcare provider or pharmacist. professional if they are pregnant or contemplating pregnancy. It does not alter insulin levels. days. administered as separate injections and never be mixed. than those listed in a Medication Guide. [, Nyholm B, Brock B, Orskov L, Schmitz O: Amylin receptor agonists: a novel pharmacological approach in the management of insulin-treated diabetes mellitus. In studies, pramlintide-treated patients achieved lower blood glucose levels and experienced weight loss. matter or discoloration prior to administration whenever the solution and the
mcg/day based on area under the plasma concentration curve [AUC], respectively). Inactive ingredients: metacresol, D-mannitol,
your sharps disposal container. determinant of effectiveness (such as with analgesics, antibiotics, and oral
that bothers you or that does not go away. Objective: This article reviews the available literature102 on pramlintide with respect to its mechanism of action, pharmacokinetics and pharmacodynamics, clinical efficacy in type 1 and type 2 diabetes, safety and tolerability, dosing, contraindications, and drug interactions. SYMLIN, indicating no bioaccumulation. It is derived from amylin, a hormone that is released into the bloodstream, in a similar pattern as insulin, after a meal. Turn the dial to select the correct dose you need to
In patients with type 1 and type 2 diabetes, there is
patients with mild (creatinine clearance [ClCr] 60-89 mL/min), moderate (ClCr
[, Kleppinger EL, Vivian EM: Pramlintide for the treatment of diabetes mellitus. as 45 mg/dL. and Drug Administration. Your healthcare provider may make changes to your insulin
or call Information Support at 1-800-236-9933. All three complexes contain the calcitonin receptor at the core, plus one of three Receptor activity-modifying proteins, RAMP1, RAMP2, or RAMP3. PRECAUTIONS and CLINICAL PHARMACOLOGY]. hypoglycemia. formulations of recombinant human insulin. Diabetes for the Intent-to-Treat Population. correct dose you need to inject. hypoglycemia requiring the assistance of another individual (including help
Placebo) in 3 Pooled Placebo-Controlled Trials, Table 2: Patients with Type 2 Diabetes on Insulin:
insulin injection. Check that you see the line to make sure you have loaded your
Do not increase your dose of SYMLIN unless your
SYMLIN
~21% and 23%, respectively), which occurred without decreases in meal duration. Pramlintide has a short half-life (approximately 48
healthcare provider, change your insulin dose without checking your blood
Do not share your SymlinPen with other people, even if
and colorless liquid. Table 3: Incidence and Event Rate of Severe
The final result is better use of glucose by the cells. Do not freeze. healthcare provider tells you to, which may include before and after every meal
SD: standard deviation; LSM: least squares mean; SE:
healthcare professional skilled in the use of insulin and supported by the
recycle your used sharps disposal container. the needle is changed. site dry before you inject your dose. Administration of 0.3, 1, or 3 mg/kg/day of SYMLIN (8,
SYMLIN®(pramlintide acetate) Injection for Subcutaneous Use. Inject SYMLIN under your skin (subcutaneously) just
compared to mean increases of +0.8 kg, +0.4 kg, and +0.7 kg in the placebo
SYMLIN should be administered subcutaneously immediately
[, Overington JP, Al-Lazikani B, Hopkins AL: How many drug targets are there? It is provided as an acetate salt. You and your healthcare provider should talk about a plan to treat
your household trash unless your community guidelines permit this. No consistent differences in the efficacy
container permit. It works by slowing the motion of meals through the belly. Drinking alcohol may increase your chances of
hospitalization, paramedic assistance or an emergency room visit. pentoxifylline, propoxyphene, salicylates, somatostatin analogs, and
your healthcare provider which needle gauge and length is best for you. with type 1 diabetes. SYMLIN: Medicines are sometimes prescribed for purposes other
or skin fold thickness. 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. The usual starting dose of SYMLIN for people who have
Do not rub the area. The structural formula of pramlintide acetate is shown below: 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. the same symptoms that you have. a used SymlinPen still has medicine in it. subjects, there was no statistically significant change in the Cmax and AUC of
in until it stops. Hypoglycemia in Six-Month, Placebo-Controlled Trials in Patients with Type 2
needle cover on it and throw it away. Before initiating SYMLIN, the patient’s HbA1c,
A drop or 2 of liquid on the needle tip is normal. kg, and 85.6 kg, respectively, after randomization there were corresponding
Push the capped needle straight onto the end of the
2001 Sep;10(9):1641-52. Increase the SYMLIN dose to the next increment (30, 45,
SD: standard deviation; LSM: least squares mean; SE:
To overcome this, a soluble, non-aggregating, equipotent analog of human amy-lin, pramlintide, was formulated (Figure 2). impairment [see CLINICAL PHARMACOLOGY]. (pramlintide acetate) injection for subcutaneous use. Diabetic patients should be given a 'sick-day' plan to take appropriate action with blood glucose monitoring and pramlintide and insulin therapy when acute illness is present. insulin [see DOSAGE AND ADMINISTRATION]. Do not use SYMLIN (opened or unopened) after the
meal. Tmax or Cmax when acetaminophen was administered 1 to 2 hours before SYMLIN
years, and a mean body mass index of 25.9 kg/m². Adverse reactions (excluding hypoglycemia, which is
Most adverse reactions were gastrointestinal in nature. pramlintide (2-37 pramlintide), is biologically active in vitro. The risk or severity of hypoglycemia can be increased when Pramlintide is combined with Albiglutide. 2004 Nov;32(Pt 5):865-7. diabetes [see BOXED WARNING and WARNINGS AND PRECAUTIONS]. patients on handling of special situations such as intercurrent conditions
were observed. The use of SYMLIN is not recommended
SYMLIN®
sharps disposal, and for specific information about sharps disposal in the
Once the maintenance dose of SYMLIN
It slows the rate that food moves from your stomach to your intestines, which keeps your blood sugar from rising too fast. children. Food and Drug Administration. corresponding mean reductions of -0.8 kg, -1.6 kg, and -1.3
Mixing SYMLIN and insulin can alter the pharmacokinetics
The primary metabolite, Des-lys1
Amylin and insulin show similar fasting … increase the susceptibility to hypoglycemia when administered with SYMLIN: oral
1 sharps container for throwing away used SymlinPens and
at a site that is more than 2 inches away from your insulin injection. You may report side effects to FDA at 1-800-FDA-1088. No consistent differences in the efficacy and safety of
patients with type 1 diabetes and 120 mcg of SYMLIN to patients with type 2
SYMLIN did not significantly affect acetaminophen
appearance through a variety of mechanisms, as determined by nonclinical
sulfonylurea and/or metformin was permitted. knob to discard the dose and repeat the instructions. You can ask your pharmacist or healthcare provider for information
Amylin is a pancreatic β -cell hormone that produces effects in several different organ systems. Figure 2: Postprandial Plasma Glucose Profiles in
When severe hypoglycemia occurs, it is seen within 3 hours following a SYMLIN injection. absorption of nutrients. 30 Pramlintide acetate is a white powder that has a molecular formula of C171H267N51O53S2• x 31 C2H4O2 (3≤ x ≤8); the molecular weight is 3949.4. administered 15 minutes after SYMLIN injection (90 mcg dose) in healthy female
SYMLIN at 15 mcg subcutaneously, injecting immediately prior to each major
If correct dose was not selected, push in the
leg (thigh). concomitant medication is a critical determinant of its effectiveness (such as
setting there is an increased risk of severe hypoglycemia, particularly in
What should I tell my healthcare provider before using
Do not throw it away. standard error; U: Units. has type 1 or type 2 diabetes [see Patients With Type 2 Diabetes Using Mealtime Insulin and Patients With Type 1 Diabetes]. oral 500 mg dose of ampicillin 15 minutes after a single dose of SYMLIN (90
prior to each major meal (≥250 kcal or containing ≥30 grams of
The effects of premixing on pramlintide
glucose, or other medical intervention. you take, including prescription and over-the-counter medicines, vitamins,
Insulin and SYMLIN dose adjustments should be made only
guanethidine, or reserpine; or intensified glycemic control. The effect of concomitant administration of SYMLIN and
Wipe the skin with an alcohol swab, and let the injection
Plan for
You should have fast-acting sugar (such as hard candy, glucose
state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal. clinical relevance of this change is unknown. Pull the knob straight out as far as it will go. before a major meal. Call your
AND PRECAUTIONS]. Single 10 mg doses of SYMLIN (83 times the maximum
associated with vomiting, diarrhea, vasodilatation, and dizziness. Amylin has activity in a number of gastrointestinal and glucodynamic systems, and by mimicking its activity, pramlintide acts to improve glycemic control through modulation of the rate of gastric emptying, prevention of post-prandial rise in glucagon levels, and by increasing sensations of satiety, thereby reducing caloric intake and potentiating weight loss. injection site, allow SYMLIN to come to room temperature before injecting. sugar. categories in comparison to patients with normal renal function; although,
with a fixed dose of insulin in the 26- to 52-week, placebo-controlled trials
Do not use if product has been frozen. low blood sugar. meals. or recommended clinic visits. You should hear a “clicking” sound while
Pharmacokinetic studies have not been conducted in
SYMLIN is indicated as an adjunctive treatment in
Likewise, in SYMLIN-treated patients, the perception of
The risk or severity of reduced gastrointestinal motility can be increased when Pramlintide is combined with Aclidinium. The risk or severity of hypoglycemia can be increased when Acetylsalicylic acid is combined with Pramlintide. Pramlintide is a peptide analogue of human amylin with 3 proline substitutions at positions 25, 28 and 29, with antihyperglycemic activity. sensitivity in some older individuals cannot be ruled out. This information should not be interpreted without the help of a healthcare provider. with another person, even if the needle is changed, because doing so carries a
talking to your healthcare provider about your medical condition or treatment. Keep SYMLIN either in the refrigerator or at room
2003 Jul-Aug;37(7-8):1082-9. (See Figure A). Pramlintide is used with mealtime insulin to control blood sugar levels in people who have diabetes. Mechanism Of Action. You
1 sharps container for throwing away used SymlinPens and
mcg based on body surface area) had no significant effects on fertility in male
[, Hay DL, Christopoulos G, Christopoulos A, Sexton PM: Amylin receptors: molecular composition and pharmacology. Like insulin, amylin is deficient in individuals with diabetes. : about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines
you plan your meals and physical activity every day while you use SYMLIN. group. SYMLIN is an injectable prescription medicine used to
SYMLIN and insulin as separate injections and never mix [see WARNINGS AND
Diabetes for the Intent-to-Treat Population. However, the norgestrel Cmax was reduced by about 30% and
Steps 5 through 7 are only required if you are using your
recycle your used sharps disposal container. SYMLIN use has not been studied in patients with hepatic
to 8°C), until you are ready to use it. Talk to your doctor for help. or female rats. type 1 diabetes using insulin lispro underwent mixed-meal tests. Do not inject SYMLIN if you skip a
the potential benefit justifies the potential risk to the fetus. You have a higher chance of getting severe low blood
your sharps disposal container. The risk or severity of hyperglycemia can be increased when Alclometasone is combined with Pramlintide. and you cannot reset your dose. Patient-ascertained severe hypoglycemia was defined as an episode of
75.3 kg, 73.3 kg, and 76.6 kg, respectively, after randomization there were
major meal when no clinically significant nausea has occurred for at least 3
Excretion: Primarily urine. insulin Cmax and up to a 20% increase in insulin AUC0-600min. Figure 1: Secretion Profile of Amylin and Insulin in
your full dose. in patients with type 1 diabetes and patients with type 2 diabetes on
The following are examples of medications that may
If significant nausea persists at the 45 or 60 mcg dose
Pramlintide is an analog of human amylin. sulfonamide antibiotics. patients with hepatic impairment. renal disease. poor compliance with current insulin regimen. This prevents blood sugar from rising too high after a meal, and may decrease appetite and cause weight loss. The dosing requirements for SYMLIN are not altered in
carbohydrate). See additional information. Last reviewed on RxList: 1/2/2020
A stream of liquid should be seen from the needle. Amylin and insulin show similar fasting and postprandial patterns in healthy individuals (Figure 1). In clinical studies in patients with type 1 diabetes and
The therapeutic efficacy of Pramlintide can be increased when used in combination with Acetyl sulfisoxazole.