Liraglutide
Generic Name: liraglutide
Brand Names:
Liraglutide
11 DESCRIPTION Liraglutide injection contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. Liraglutide is manufactured by synthetic process. The peptide precursor of liraglutide has been manufactured to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor.
Overview
11 DESCRIPTION Liraglutide injection contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. Liraglutide is manufactured by synthetic process. The peptide precursor of liraglutide has been manufactured to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor.
Uses
1 INDICATIONS AND USAGE Liraglutide injection is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity. Adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products or with any other glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. The safety and effectiveness of liraglutide injection in pediatric patients with type 2 diabetes have not been established.
Dosage
2 DOSAGE AND ADMINISTRATION Inject liraglutide injection subcutaneously in the abdomen, thigh, or upper arm once daily at any time of day, without regard to the timing of meals. ( 2.1 ) The recommended dose of liraglutide injection is 3 mg daily ( 2.2 ). Initiate at 0.6 mg per day for one week. In weekly intervals, increase the dose until a dose of 3 mg is reached. ( 2.2 ) If pediatric patients do not tolerate an increased dose during dose escalation, the dose may also be lowered to the previous level. Dose escalation for pediatric patients may take up to 8 weeks. ( 2.2 ) Pediatric patients who do not tolerate 3 mg daily may have their dose reduced to 2.4 mg daily.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-Cell Tumors [see Warnings and Precautions ( 5.1 )] Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.3 )] Risk for Hypoglycemia with Concomitant Use of Anti-Diabetic Therapy [see Warnings and Precautions ( 5.4 )] Heart Rate Increase [see Warnings and Precautions ( 5.5 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.6 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.7 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.9 )] Pulmonary Aspirat...
Interactions
7 DRUG INTERACTIONS Liraglutide injection delays gastric emptying. May impact absorption of concomitantly administered oral medications. Use with caution. ( 7 ) 7.1 Oral Medications Liraglutide injection causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials, liraglutide did not affect the absorption of the tested orally administered medications to any clinically relevant degree. Nonetheless, monitor for potential consequences of delayed absorption of oral medications concomitantly administered with liraglutide injection.
Warnings
WARNING: RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide injection causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ) and Nonclinical Toxicology ( 13.1 )] .... 5 WARNINGS AND PRECAUTIONS Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including liraglutide injection. Discontinue if pancreatitis is suspected. ( 5.2 ) Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated. ( 5.3 ) Hypoglycemia: Can occur in adults when liraglutide injection is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin. The risk may be lowered by a reduction in the dose of concomitantly administered insulin secretagogues or insulin. In the pediatric clinical trial, patients did not have type 2 diabetes. Hypoglycemia occurred in liraglutide - treated pediatric patients. 4 CONTRAINDICATIONS Liraglutide injection is contraindicated in: Patients with a personal or family history of medullary thyroid carcinoma (MTC) or patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions ( 5.1 )] . Patients with a serious hypersensitivity reaction to liraglutide or to any of the excipients in liraglutide injection.
Pregnancy
8.1 Pregnancy Risk Summary Based on animal reproduction studies, there may be risks to the fetus from exposure to liraglutide injection during pregnancy. Liraglutide injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Additionally, weight loss offers no benefit to a pregnant patient and may cause fetal harm. When a pregnancy is recognized, advise the pregnant patient of the risk to a fetus, and discontinue liraglutide injection (see Clinical Considerations) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Liraglutide injection: 6 mg/mL clear, colorless solution in a 3 mL single-patient-use pre-filled pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3 mg is available in the following package sizes: 3 x Liraglutide Injection Pen NDC 69097-910-68 5 x Liraglutide Injection Pen NDC 69097-910-55 Recommended Storage Prior to first use, liraglut...
Frequently Asked Questions
What is Liraglutide used for?▼
1 INDICATIONS AND USAGE Liraglutide injection is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity. Adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products or with any other glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. The safety and effectiveness of liraglutide injection in pediatric patients with type 2 diabetes have not been established.
What are the side effects of Liraglutide?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-Cell Tumors [see Warnings and Precautions ( 5.1 )] Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.3 )] Risk for Hypoglycemia with Concomitant Use of Anti-Diabetic Therapy [see Warnings and Precautions ( 5.4 )] Heart Rate Increase [see Warnings and Precautions ( 5.5 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.6 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.7 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.9 )] Pulmonary Aspirat...
Can I take Liraglutide during pregnancy?▼
8.1 Pregnancy Risk Summary Based on animal reproduction studies, there may be risks to the fetus from exposure to liraglutide injection during pregnancy. Liraglutide injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Additionally, weight loss offers no benefit to a pregnant patient and may cause fetal harm. When a pregnancy is recognized, advise the pregnant patient of the risk to a fetus, and discontinue liraglutide injection (see Clinical Considerations) .
What are the important warnings for Liraglutide?▼
WARNING: RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide injection causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ) and Nonclinical Toxicology ( 13.1 )] .... 5 WARNINGS AND PRECAUTIONS Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including liraglutide injection. Discontinue if pancreatitis is suspected. ( 5.2 ) Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated. ( 5.3 ) Hypoglycemia: Can occur in adults when liraglutide injection is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin. The risk may be lowered by a reduction in the dose of concomitantly administered insulin secretagogues or insulin. In the pediatric clinical trial, patients did not have type 2 diabetes. Hypoglycemia occurred in liraglutide - treated pediatric patients. 4 CONTRAINDICATIONS Liraglutide injection is contraindicated in: Patients with a personal or family history of medullary thyroid carcinoma (MTC) or patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions ( 5.1 )] . Patients with a serious hypersensitivity reaction to liraglutide or to any of the excipients in liraglutide injection.
Related Medications
Valrubicin
valrubicin
11 DESCRIPTION VALSTAR contains valrubicin (N-trifluoroacetyladriamycin-14-valerate), which is a semisynthetic analog of the anthracycline doxorubicin as a cytotoxic agent. The chemical name of valrubicin is (2 S - cis )-2-[1,2,3,4,6,11-hexahydro-2,5,12-trihydroxy-7-methoxy-6,11-dioxo-4-[[2,3,6-trideoxy-3-[(trifluoroacetyl)amino]-α-L- lyxo -hexopyranosyl]oxyl]-2-naphthacenyl]-2-oxoethylpentanoate.
Diazepam Intensol
diazepam intensol
Benzodiazepine [EPC]
DESCRIPTION Each mL of Diazepam Intensol TM Oral Solution (Concentrate) contains: diazepam, USP.........................................................5 mg alcohol......................................................................19% Inactive Ingredients alcohol, D&C Yellow No. 10, polyethylene glycol, propylene glycol, succinic acid and water. Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-Chloro-1,3-dihydro-1-methyl-5-phenyl-2 H -1,4-benzodiazepin-2-one.
Amiloride Hydrochloride And Hydrochlorothiazide
amiloride hydrochloride and hydrochlorothiazide
Thiazide Diuretic [EPC]
DESCRIPTION Amiloride hydrochloride and hydrochlorothiazide tablets, USP combine the potassium-conserving action of amiloride hydrochloride with the natriuretic action of hydrochlorothiazide. Amiloride HCl, USP is designated chemically as N -amidino-3,5,-diamino-6-chloropyrazine-carboxamide monohydrochloride dihydrate and its structural formula is: C 6 H 8 CIN 7 O•HCl•2H 2 O M.W.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.