Liraglutide

Liraglutide is aprescriptionmedicationused to treat the symptoms of Type 2Diabetes MellitusandObesity.

• Liraglutide is available under the following different brand names:Saxenda

Dosages of Liraglutide:

Adult andPediatricdosage

SC solution multidose pen

• 18mg/3mL (Victoza); delivers doses of 0.6mg, 1.2mg, or 1.8mg
• 18mg/3mL (Saxenda); delivers doses of 0.6mg, 1.2mg, 1.8mg, 2.4mg, or 3mg

Type 2 DiabetesMellitus

Victoza only

Adults

• 0.6 mg SC daily for 1 week initially, then increase to 1.2 mg once daily
• If glycemiccontrolis not achieved, can increase to 1.8 mg once daily
• The initial dose of 0.6mg SC daily is only the decreasedGIadverse effects and does not provide glycemic control

Pediatric

• Children 10 years of age or older with type 2diabetesmellitus
• 0.6mg SC once daily for 1 week, may increase the dose to 1.2 mg/day if additional glycemic control is required
• If additional glycemic control is required, may increase to 1.8 mg once daily after at least 1 week after 1.2 mg once daily dose

Obesity

Saxenda only

Adults

• Initiate at 0.6 mg SC once daily for 1 week; increase by 0.6 mg per dayinweekly intervals until a dose of 3 mg per day is achieved

Pediatric

• Initiate at 0.6mg SC once daily for 1 week; increase by 0.6 mg/day in weekly intervals until a dose of 3 mg/day achieved
• The recommended maintenance dose is 3 mg/day; if unable to tolerate, may reduce to 2.4 mg/day; discontinue if 2.4 mg is not tolerated

Dosage Considerations – Should be Given as Follows:

• See “Dosages”.

Common side effects of Liraglutide include:

• 低血糖,
• nausea,
• vomiting,
• stomachdiscomfort,
• loss of appetite,
• diarrhea,
• constipation,
• rash,
• headache,
• dizziness, and
• tiredness

Serious side effects of Liraglutide include:

• hives,
• fast heartbeats,
• dizziness,
• troublebreathing,
• difficulty swallowing,
• 肿胀of the face,lips,tongue, orthroat,
• racing or pounding heartbeats,
• sudden changes in mood or behavior,
• thoughts ofself-harm,
• feeling very thirsty or hot,
• being unable to urinate,
• heavysweating,
• hot anddry skin,
• headache,
• hunger,
• sweating,
• 易怒,
• dizziness,
• anxiety,
• shakiness,
• sudden and severepainin the upper stomach that may spread to the back,
• nausea,
• vomiting,
• fever,
• yellowing of theskinor eyes (jaundice),
• 肿胀or a lump in theneck,
• hoarse voice, and
• shortness of breath

Liraglutide罕见的副作用包括:

• none

This is not a complete list of side effects and other serious side effects orhealthproblems may occur as a result of the use of this drug. Call yourdoctorfor medical advice about serious side effects or adverse reactions. You may report side effects or health problems toFDAat 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor orpharmacistmay already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Liraglutide has severe interactions with no other drugs.
• Liraglutide has serious interactions with no other drugs.
• Liraglutide has moderate interactions with at least 111 other drugs.
• Liraglutide hasminorinteractions with the following drugs:
  • acetaminophen
  • acetaminophen IV
  • digoxin
  • lovastatin

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity to Liraglutide or its components
• Patients with a personal orfamily historyof medullarythyroidcarcinoma(MTC) or patients with multipleendocrineneoplasiasyndrometypes 2 (MEN 2)
• Saxenda only:Pregnancy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Liraglutide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Liraglutide?”

Cautions

• Acute pancreatitis, including fatal and non-fatalhemorrhagicor necrotizingpancreatitis, has been observed; studied in a limited number of patients with a history of pancreatitis; unknown if patients with a history of pancreatitis are at higher risk fordevelopmentof pancreatitis
• Acutegallbladderdiseasereported; ifcholelithiasisis suspected, gallbladder studies and follow-up appropriately
• May cause dose-dependent and treatment-duration-dependent thyroid C-celltumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice; ifserumcalcitoninis elevated, evaluate further; patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated
• RenalImpairment reported inassociationwith nausea, vomiting, diarrhea, ordehydration, which may sometimes requirehemodialysis; altered renal function has been reversed in many of reported cases with supportive treatment and discontinuation of potentially causative agents; use caution when initiating or escalating doses of in these patients
• There have been posted marketing reports of serious hypersensitivity reactions (eg, anaphylactic reactions,angioedema)
• Never share pen between patients even if the needle is changed

Saxenda only

• Restingheart ratemay increase by 2-3 bpm; up to 10-20 bpm increases also reported
• Suicidalideation; monitor for the emergence or worsening ofdepression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior; discontinue in patients who experience suicidal thoughts or behaviors; avoid in patients with a history of suicidal attempts or active suicidal ideation

Drug interactions overview

• May cause a delay ofgastricemptying and thereby has the potential toimpacttheabsorptionof concomitantly administeredoralmedications; exercise caution when oral medications are concomitantly administered with liraglutide
• Risk forHypoglycemiawith Concomitant Use of AntidiabeticTherapy
• The risk for hypoglycemia is increased when Saxenda is used in combination withinsulinsecretagogues (ie, sulfonylureas) or insulin in patients with type 2 Diabetes Mellitus
• In patients with type 2 diabetes, monitorblood glucosebefore starting therapy and during treatment
• Therefore, patients may require a lower dose ofsulfonylurea(or other concomitantly administered insulin secretagogues) or insulin in this setting
• Victoza only: In pediatric patients 10 years of age or older, the risk of hypoglycemia was higher regardless of concomitant antidiabetic therapies

Pregnancy andLactation

Victoza

• Based on animalreproductionstudies, there may be risks to thefetusfrom exposure during pregnancy
• 在怀孕期间使用only if the potential benefit justifies the potential risk to the fetus

Saxenda

• Contraindicated during pregnancy becauseweight lossoffers no potential benefit to apregnantwoman and may result in fetal harm
• There are no availabledatain pregnant women to inform a drug-associated risk formajorbirth defects andmiscarriage
• If apatientwishes to become pregnant, or pregnancy occurs, discontinue treatment
• A minimum weight gain, and no weight loss, recommended for all pregnant women, including those who are alreadyoverweightorobese, due to necessary weight gain that occurs inmaternaltissues during pregnancy

ClinicalConsiderations

• Disease-associated maternal and/orembryo/fetal risk
• Poorly controlled diabetes in pregnancy increases the maternal risk fordiabetic ketoacidosis,preeclampsia, spontaneous abortions, preterm delivery, and delivery complications
• Poorly controlled diabetes increases the fetal risk for major birth defects,stillbirth, andmacrosomiarelatedmorbidity
• There are no data on the presence of drugs in human milk, the effects on the breastfedinfant, or the effects on milk production
• Present in the milk of lactating rats