Amylin Pharmaceuticals, Llc

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Amylin Pharmaceuticals, Llc Drugs

Myalept

Myalept

2.1 Recommended Dosing

See Table 1 for the recommended daily dose and maximum recommended daily dose in adults and pediatric patients.

Based on clinical response (e.g., inadequate metabolic control) or other considerations (e.g., tolerability issues, excessive weight loss [especially in pediatric patients]), MYALEPT dosage may be decreased or increased to the maximum dosage listed in Table 1.
Table 1: MYALEPT Recommended Dosage Baseline Weight Starting Daily Dose (injection volume) Dose Adjustments (injection volume) Maximum Daily Dose (injection volume)
Less than or equal to 40 kg(males and females)

0.06 mg/kg(0.012 mL/kg)

0.02 mg/kg(0.004 mL/kg)

0.13 mg/kg(0.026 mL/kg)

Males greater than 40 kg

2.5 mg(0.5 mL)

1.25 mg (0.25 mL) to2.5 mg (0.5 mL)

10 mg(2 mL)

Females greater than 40 kg

5 mg (1 mL)

1.25 mg (0.25 mL) to2.5 mg (0.5 mL)

10 mg(2 mL)

MYALEPT should be administered once daily at the same time every day. MYALEPT can be administered any time of day without regard to the timing of meals.

Instruct patients that if a dose is missed, administer the dose as soon as noticed, and resume the normal dosing schedule the next day.

2.2 MYALEPT Preparation and Storage

Healthcare practitioners should provide proper training to patients and caregivers regarding how to prepare and administer the correct dose of MYALEPT prior to self-use. The patients and caregivers should prepare and administer the first dose of MYALEPT under the supervision of a qualified healthcare professional.

Instruct patients to store the vials of lyophilized powder in their carton in the refrigerator as soon as received [see How Supplied/Storage and Handling (16.2)].

MYALEPT can be reconstituted aseptically with 2.2 mL of sterile Bacteriostatic Water for Injection (BWFI), USP (0.9% benzyl alcohol), or with 2.2 mL of sterile Water for Injection (WFI).

When reconstituted in BWFI, MYALEPT solution can be used within 3 days when stored in the refrigerator between 36°F and 46°F (2°C and 8°C) and protected from light [see How Supplied/Storage and Handling (16.2)]. Discard unused reconstituted solution after 3 days. Attach the supplied sticker to the vial and enter the discard date.

For use in neonates and infants, reconstitute with preservative-free sterile WFI [see Warnings and Precautions (5.7) and Use in Specific Populations (8.4)]. When reconstituted in sterile WFI, MYALEPT should be administered immediately. Unused reconstituted solution cannot be saved for later use and should be discarded.

Reconstitution of the Lyophilized Powder

Instruct patients to follow the directions below for reconstitution of the lyophilized powder:
a) Remove the vial containing the MYALEPT lyophilized powder from the refrigerator and allow the vial to warm to room temperature prior to use. b) Visually inspect the vial containing MYALEPT. The cake of lyophilized powder should be intact and white in color. c) Using a 3-mL syringe with a 22-gauge or smaller diameter needle withdraw 2.2 mL of sterile Bacteriostatic Water for Injection (BWFI) or preservative-free sterile Water for Injection (WFI). Do not reconstitute MYALEPT with other diluents. d) Inject the BWFI or WFI into the vial containing the lyophilized powder of MYALEPT, slowly injecting down the side of the vial. It is normal for some bubbles to form. e) Remove the needle and syringe from the vial and gently swirl the contents to reconstitute. Do not shake or vigorously agitate. When properly mixed, the MYALEPT reconstituted solution should be clear and free of clumps or dry powder, bubbles or foam. Do not use the solution if discolored or cloudy, or if particulate matter remains. f) Regarding the compatibility of MYALEPT reconstituted solution with other solutions: • Do not mix with, or transfer into, the contents of another vial of MYALEPT. • Do not add other medications, including insulin. Use a separate syringe for insulin injections.
See the MYALEPT Instructions for Use for complete administration instructions. The instructions can also be found at www.myalept.com.

2.3 Administration Instructions

Healthcare practitioners should instruct patients and caregivers on the proper subcutaneous injection technique with care to avoid intramuscular injection in patients with minimal subcutaneous adipose tissue. Never administer MYALEPT intravenously or intramuscularly.

Instruct patients to follow the recommended injection technique:
a) Using a 1-mL syringe with a needle appropriate for subcutaneous injection, withdraw the prescribed dose of MYALEPT reconstituted solution. b) Remove any large air pockets or large bubbles from the filled syringe prior to administration. Some small bubbles may remain in the syringe. c) Administer MYALEPT into the subcutaneous tissue of the abdomen, thigh or upper arm. Advise patients to use a different injection site each day when injecting in the same region. After choosing an injection site, pinch the skin and at a 45-degree angle, inject the MYALEPT reconstituted solution subcutaneously. Avoid intramuscular injection, especially in patients with minimal subcutaneous adipose tissue. d) Doses exceeding 1 mL can be administered as two injections (the total daily dose divided equally) to minimize potential injection-site discomfort due to injection volume. When dividing doses due to volume, doses can be administered one after the other.
Do not mix MYALEPT with insulin. Use a separate syringe for each medication. If MYALEPT and insulin are administered at the same time of day, they may be injected in the same body area using two different injection sites.

See the MYALEPT Instructions for Use for complete administration instructions. The instructions can also be found at www.myalept.com.

2.4 Dosage Adjustments of Medications Known to Cause Hypoglycemia

Dosage adjustments, including possible large reductions, of insulin or insulin secretagogue (e.g., sulfonylurea) may be necessary in some patients to minimize the risk of hypoglycemia [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)]. Closely monitor blood glucose in patients on concomitant insulin therapy, especially those on high doses, or insulin secretagogue (e.g., sulfonylurea) when treating with MYALEPT.

2.5 Discontinuation in Patients at Risk for Pancreatitis

When discontinuing MYALEPT therapy in patients with risk factors for pancreatitis (e.g., history of pancreatitis, severe hypertriglyceridemia), tapering of the dose over a one-week period is recommended. During tapering, monitor triglyceride levels and consider initiating or adjusting the dose of lipid-lowering medications as needed. Signs and/or symptoms consistent with pancreatitis should prompt an appropriate clinical evaluation.
Atorvastatin Calcium

Atorvastatin Calcium

2.1 Recommended Dosing

BYDUREON (2 mg per dose) should be administered once every 7 days (weekly). The dose can be administered at any time of day, with or without meals.

Missed Dose

If a dose is missed, it should be administered as soon as noticed, provided the next regularly scheduled dose is due at least 3 days later. Thereafter, patients can resume their usual dosing schedule of once every 7 days (weekly).

If a dose is missed and the next regularly scheduled dose is due 1 or 2 days later, the patient should not administer the missed dose and instead resume BYDUREON with the next regularly scheduled dose.

Changing Weekly Dosing Schedule

The day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before.

2.2 Administration

BYDUREON must be injected immediately after the dose is prepared. BYDUREON is administered as a subcutaneous (SC) injection in the abdomen, thigh, or upper arm region. Advise patients to use a different injection site each week when injecting in the same region. BYDUREON must not be administered intravenously or intramuscularly. BYDUREON is intended for patient self-administration.

Prior to initiation of BYDUREON, patients should be trained by their healthcare professional. For the BYDUREON Pen, study data demonstrated that training reduced the risk of administration errors such as inadequate mixing or incomplete dosing. Patients using the BYDUREON Pen should be trained on proper mixing and injection technique to ensure the product is adequately mixed and a full dose is delivered. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. The instructions can also be found at www.bydureon.com.

2.3 Changing from BYETTA to BYDUREON

Prior treatment with BYETTA is not required when initiating BYDUREON therapy. If the decision is made to start BYDUREON in an appropriate patient already taking BYETTA, BYETTA should be discontinued. Patients changing from BYETTA to BYDUREON may experience transient (approximately 2 weeks) elevations in blood glucose concentrations.

2.1 Recommended Dosing

BYDUREON (2 mg per dose) should be administered once every 7 days (weekly). The dose can be administered at any time of day, with or without meals.

Missed Dose

If a dose is missed, it should be administered as soon as noticed, provided the next regularly scheduled dose is due at least 3 days later. Thereafter, patients can resume their usual dosing schedule of once every 7 days (weekly).

If a dose is missed and the next regularly scheduled dose is due 1 or 2 days later, the patient should not administer the missed dose and instead resume BYDUREON with the next regularly scheduled dose.

Changing Weekly Dosing Schedule

The day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before.

Missed Dose

If a dose is missed, it should be administered as soon as noticed, provided the next regularly scheduled dose is due at least 3 days later. Thereafter, patients can resume their usual dosing schedule of once every 7 days (weekly).

If a dose is missed and the next regularly scheduled dose is due 1 or 2 days later, the patient should not administer the missed dose and instead resume BYDUREON with the next regularly scheduled dose.

Changing Weekly Dosing Schedule

The day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before.

2.2 Administration

BYDUREON must be injected immediately after the dose is prepared. BYDUREON is administered as a subcutaneous (SC) injection in the abdomen, thigh, or upper arm region. Advise patients to use a different injection site each week when injecting in the same region. BYDUREON must not be administered intravenously or intramuscularly. BYDUREON is intended for patient self-administration.

Prior to initiation of BYDUREON, patients should be trained by their healthcare professional. For the BYDUREON Pen, study data demonstrated that training reduced the risk of administration errors such as inadequate mixing or incomplete dosing. Patients using the BYDUREON Pen should be trained on proper mixing and injection technique to ensure the product is adequately mixed and a full dose is delivered. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. The instructions can also be found at www.bydureon.com.

2.3 Changing from BYETTA to BYDUREON

Prior treatment with BYETTA is not required when initiating BYDUREON therapy. If the decision is made to start BYDUREON in an appropriate patient already taking BYETTA, BYETTA should be discontinued. Patients changing from BYETTA to BYDUREON may experience transient (approximately 2 weeks) elevations in blood glucose concentrations.
Byetta

Byetta

2.1 Recommended Dosing

BYETTA should be initiated at 5 mcg administered twice daily (BID) at any time within the 60-minute period before the morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart). BYETTA should not be administered after a meal. Based on clinical response, the dose of BYETTA can be increased to 10 mcg twice daily after 1 month of therapy. Initiation with 5 mcg reduces the incidence and severity of gastrointestinal side effects. Each dose should be administered as a subcutaneous (SC) injection in the thigh, abdomen, or upper arm. Do not mix BYETTA with insulin. Do not transfer BYETTA from the pen to a syringe or a vial. No data are available on the safety or efficacy of intravenous or intramuscular injection of BYETTA.

Use BYETTA only if it is clear, colorless and contains no particles.

2.1 Recommended Dosing

BYETTA should be initiated at 5 mcg administered twice daily (BID) at any time within the 60-minute period before the morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart). BYETTA should not be administered after a meal. Based on clinical response, the dose of BYETTA can be increased to 10 mcg twice daily after 1 month of therapy. Initiation with 5 mcg reduces the incidence and severity of gastrointestinal side effects. Each dose should be administered as a subcutaneous (SC) injection in the thigh, abdomen, or upper arm. Do not mix BYETTA with insulin. Do not transfer BYETTA from the pen to a syringe or a vial. No data are available on the safety or efficacy of intravenous or intramuscular injection of BYETTA.

Use BYETTA only if it is clear, colorless and contains no particles.
Symlinpen

Symlinpen

2.1 Important Considerations Pertaining to SYMLIN and Insulin Dose Adjustments

SYMLIN dosage differs depending on whether the patient has type 1 or type 2 diabetes [see Dosage and Administration (2.2, 2.3)].

SYMLIN should be used only in patients who can fully understand and adhere to proper insulin adjustments and glucose monitoring.

Insulin and SYMLIN dose adjustments should be made only as directed by a healthcare professional skilled in the use of insulin.

When initiating SYMLIN, reduce mealtime insulin doses, including premixed insulins, by 50% to reduce the risk of hypoglycemia.

To reduce the risk of nausea, wait at least 3 days before titrating SYMLIN to the next dose increment.

Monitor blood glucoses frequently, including pre- and post-meals and at bedtime, particularly when initiating SYMLIN or increasing the SYMLIN dose. After the initial 50% reduction in mealtime insulin dose, individualize insulin dose adjustments based on glycemic control and tolerability (e.g., if nausea occurs it may affect the dose of insulin required). An increased frequency of mild-to-moderate hypoglycemia should be viewed as a warning sign of increased risk for severe hypoglycemia.

If SYMLIN therapy is discontinued for any reason (e.g., surgery or illnesses), the same initiation protocol should be followed when SYMLIN therapy is reinstituted [see Dosage and Administration (2.2)].

2.2 Patients with Type 2 Diabetes Using Mealtime Insulin

Reduce mealtime insulin doses (including premixed insulins) by 50%, then initiate SYMLIN at 60 mcg subcutaneously, injecting immediately prior to each major meal.

Increase the SYMLIN dose from 60 to 120 mcg prior to each major meal when no clinically significant nausea has occurred for at least 3 days.

If significant nausea persists at the 120 mcg dose, the SYMLIN dose should be decreased to 60 mcg.

2.3 Patients with Type 1 Diabetes

Reduce mealtime insulin doses by 50%, then initiate SYMLIN at 15 mcg subcutaneously, injecting immediately prior to each major meal.

Increase the SYMLIN dose to the next increment (30, 45, or 60 mcg) when no clinically significant nausea has occurred for at least 3 days.

If significant nausea persists at the 45 or 60 mcg dose level, the SYMLIN dose should be decreased to 30 mcg. If the 30 mcg dose is not tolerated, discontinuation of SYMLIN therapy should be considered.

2.4 Administration

SYMLIN should be administered subcutaneously immediately prior to each major meal (≥250 kcal or containing ≥30 grams of carbohydrate).

SYMLIN should be at room temperature before injecting to reduce potential injection site reactions. Each SYMLIN dose should be administered subcutaneously into the abdomen or thigh. Administration into the arm is not recommended because of variable absorption. Injection sites should be rotated so that the same site is not used repeatedly. The injection site selected should also be distinct from the site chosen for any concomitant insulin injection.

SYMLIN and insulin should always be administered as separate injections.

SYMLIN should not be mixed with any type of insulin.

If a SYMLIN dose is missed, wait until the next scheduled dose and administer the usual amount.

2.5 Discontinuation of Therapy

SYMLIN therapy should be discontinued if there is:
• recurrent unexplained hypoglycemia that requires medical assistance. • persistent clinically significant nausea. • noncompliance with self-monitoring of blood glucose concentrations. • noncompliance with insulin dose adjustments. • noncompliance with scheduled healthcare provider contacts or recommended clinic visits.
2.6 Preparation and Handling

SYMLIN should be inspected visually for particulate matter or discoloration prior to administration whenever the solution and the container permit.

Amylin Pharmaceuticals, Llc

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Amylin Pharmaceuticals, Llc Drugs