Aegerion Pharmaceuticals, Inc.

Aegerion Pharmaceuticals, Inc. Drugs

• Complete Allergy Medici...
  

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  Complete Allergy Medicine

  

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  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.

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• Juxtapid
  

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  Juxtapid

  

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  2.1 Initiation and Maintenance of Therapy

  Before beginning treatment with JUXTAPID:

  Measure transaminases (ALT, AST), alkaline phosphatase, and total bilirubin [see Warnings and Precautions (5.1)]; Obtain a negative pregnancy test in females of reproductive potential [see Warnings and Precautions (5.3)]; and, Initiate a low-fat diet supplying <20% of energy from fat [see Warnings and Precautions (5.5)].

  The recommended starting dosage of JUXTAPID is 5 mg once daily, and the dose should be escalated gradually based on acceptable safety and tolerability. Transaminases should be measured prior to any increase in dose [see Warnings and Precautions (5.1)]. The maintenance dosage of JUXTAPID should be individualized, taking into account patient characteristics such as goal of therapy and response to treatment, to a maximum of 60 mg daily as described in Table 1. Modify dosing for patients taking concomitant CYP3A4 inhibitors, renal impairment, or baseline hepatic impairment [see Dosage and Administration (2.3), (2.5), and (2.6)]. Dose adjustments are also required for patients who develop transaminase values ≥3x the upper limit of normal (ULN) during treatment with JUXTAPID [see Dosage and Administration (2.4)].

  Table 1: Recommended Regimen for Titrating Dosage DOSAGE DURATION OF ADMINISTRATION BEFORE CONSIDERING INCREASE TO NEXT DOSAGE 5 mg daily At least 2 weeks 10 mg daily At least 4 weeks 20 mg daily At least 4 weeks 40 mg daily At least 4 weeks 60 mg daily Maximum recommended dosage

  To reduce the risk of developing a fat-soluble nutrient deficiency due to JUXTAPID’s mechanism of action in the small intestine, patients treated with JUXTAPID should take daily supplements that contain 400 international units vitamin E and at least 200 mg linoleic acid, 210 mg alpha-linolenic acid (ALA), 110 mg eicosapentaenoic acid (EPA), and 80 mg docosahexaenoic acid (DHA) [see Warnings and Precautions (5.4)].

  2.2 Administration

  JUXTAPID should be taken once daily with a glass of water, without food, at least 2 hours after the evening meal because administration with food may increase the risk of gastrointestinal adverse reactions [see Warnings and Precautions (5.5)]. Patients should swallow JUXTAPID capsules whole. Capsules should not be opened, crushed, dissolved, or chewed.

  2.3 Dosing with Cytochrome P450 3A4 Inhibitors

  JUXTAPID is contraindicated with concomitant use of moderate and strong cytochrome P450 3A4 (CYP3A4) inhibitors [see Contraindications (4) and Drug Interactions (7.1)].

  The recommended maximum dosage of JUXTAPID is 30 mg daily with concomitant use of weak CYP3A4 inhibitors (such as alprazolam, amiodarone, amlodipine, atorvastatin, bicalutamide, cilostazol, cimetidine, cyclosporine, fluoxetine, fluvoxamine, ginkgo, goldenseal, isoniazid, lapatinib, nilotinib, oral contraceptives, pazopanib, ranitidine, ranolazine, ticagrelor, zileuton) [see Drug Interactions (7.2)].

  2.4 Dose Modification Based on Elevated Transaminases

  Table 2 summarizes recommendations for dose adjustment and monitoring for patients who develop elevated transaminases during therapy with JUXTAPID [see Warnings and Precautions (5.1)].

  Table 2: Dose Adjustment and Monitoring for Patients with Elevated Transaminases *Recommendations based on an ULN of approximately 30-40 international units/L. ALT OR AST TREATMENT AND MONITORING RECOMMENDATIONS* ≥3x and <5x ULN Confirm elevation with a repeat measurement within one week. If confirmed, reduce the dose and obtain additional liver-related tests if not already measured (such as alkaline phosphatase, total bilirubin, and INR). Repeat tests weekly and withhold dosing if there are signs of abnormal liver function (increase in bilirubin or INR), if transaminase levels rise above 5x ULN, or if transaminase levels do not fall below 3x ULN within approximately 4 weeks. In these cases of persistent or worsening abnormalities, also investigate to identify the probable cause. If resuming JUXTAPID after transaminases resolve to <3x ULN, consider reducing the dose and monitor liver-related tests more frequently. ≥5x ULN Withhold dosing, obtain additional liver-related tests if not already measured (such as alkaline phosphatase, total bilirubin, and INR), and investigate to identify the probable cause. If resuming JUXTAPID after transaminases resolve to <3x ULN, reduce the dose and monitor liver-related tests more frequently.

  If transaminase elevations are accompanied by clinical symptoms of liver injury (such as nausea, vomiting, abdominal pain, fever, jaundice, lethargy, flu-like symptoms), increases in bilirubin ≥2x ULN, or active liver disease, discontinue treatment with JUXTAPID and investigate to identify the probable cause [see Warnings and Precautions (5.1)].

  2.5 Dosing in Patients with Renal Impairment

  Patients with end-stage renal disease receiving dialysis should not exceed 40 mg daily. There are no data available to guide dosing in other patients with renal impairment [see Use in Specific Populations (8.7)].

  2.6 Dosing in Patients with Baseline Hepatic Impairment

  Patients with mild hepatic impairment (Child-Pugh A) should not exceed 40 mg daily [see Use in Specific Populations (8.8)].

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