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Saxenda Weight-Loss Pens

5 pens for $514.99

Saxenda Pre-Filled Pen - 6mg/mL
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Description

Saxenda (liraglutide) injection 3 mg is an injectable prescription medicine that may help some adults with excess weight, BMI 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g. hypertension, type 2 diabetes mellitus, or dyslipidemia). Saxenda should be used with a reduced-calorie meal plan and increased physical activity.

A more significant number of people who took Saxenda for 56 weeks lost 5 to 10% of their body weight compared with those who received a placebo. (Placebos are substances that have no effect and are used as controls when testing medications). In other words, participants lost between 12 and 23 pounds. Before taking Saxenda, participants were overweight (BMI 27-29.9 kg/m2) or obese (BMI greater than 30 kg/m2).

Tell your healthcare provider about any medications you take, including prescriptions, over the counter medications, vitamins, and herbal supplements.

Saxenda slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Saxenda is not known to be safe or effective in children under 12 years old. Saxenda is not known to be safe or effective in children with type 2 diabetes aged 12 to 17 years. Pediatric patients aged 12 years and older with a  body weight above 60 kg and/or initial BMI corresponding to 30 kg/m2 for adults (obese) by international cut-offs, may be prescribed liraglutide. 

Saxenda slows stomach emptying and may affect the way some medications work and some other medicines may affect the way this medication works.

Saxenda is not for the treatment of type 2 diabetes nor should be combined with insulin. There is no specific diet with Saxenda but it would be beneficial to understand the foods to avoid.

Warnings & Precautions

Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda 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.

Saxenda is contraindicated in patients with a personal or family history of MTC or patients with Multiple Endocrine Neoplasia syndrome type 2. Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors.

Saxenda contains liraglutide and should not be co-administered with other liraglutide-containing products or any other GLP-1 receptor agonist.

The safety and effectiveness of Saxenda in pediatric patients with type 2 diabetes have not been established.

The safety and efficacy of Saxenda in combination with other products intended for weight loss have not been established.

Saxenda and Victoza have the same active ingredient, liraglutide, and should not be used together or with other GLP-1 receptor agonist medicines.

It is unknown if Saxenda is safe and effective when taken with other prescriptions, over-the-counter medicines, or herbal weight-loss products. It is also not known if it is safe and effective in children under 12.

Before Taking Saxenda

Saxenda should not be used if you are allergic to liraglutide, or if you have:

  • Multiple endocrine neoplasia type 2 (tumors in the glands);
  • A history of medullary thyroid carcinoma (a type of thyroid cancer); or
  • Ketoacidosis in diabetics (consult your doctor).

If you also take insulin or other medicines like liraglutide (albiglutide, dulaglutide, exenatide, Byetta, Bydureon, Tanzeum, Trulicity), Saxenda should not be used.

Tell your doctor if you have any of the following conditions before taking Saxenda:

  • Slow digestion due to stomach problems;
  • Diseases of the kidneys or liver;
  • High triglycerides (a type of fat);
  • Problems with the heart;
  • Having problems with your pancreas or gallbladder;
  • Suicidal thoughts or a history of depression.

There has been evidence that liraglutide causes thyroid cancer or thyroid tumors in animals. Whether these effects would occur in people who take regular doses is unknown. Consult your doctor about your risk.

Unborn babies are not known to be harmed by Saxenda. If you are pregnant or plan to become pregnant, tell your doctor.

Liraglutide may pass into breast milk, but its effects on nursing infants are unknown. If you are breastfeeding, tell your doctor.

 

Common Side Effects

Common side effects of Saxenda include nausea, diarrhea, constipation, headache, vomiting, low blood sugar (hypoglycemia), decreased appetite, upset stomach, tiredness, dizziness, stomach pain, and changes in enzyme (lipase) levels in your blood. Nausea is most common when first starting Saxenda but decreases over time in most people as their body gets used to the medicine.

Tell your healthcare professional if you have any side effect that bothers you or does not go away.

Severe Side Effects

As with all medication, Saxenda may cause common or severe side effects with usage. Please speak to your healthcare provider in determining if Saxenda is suitable for you. A few of the side effects should be taken seriously, as they can result in death.

Thyroid Tumors

Saxenda may cause possible thyroid tumors, including cancer.  Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and carcinomas) at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda will cause 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. Cases of MTC in patients treated with liraglutide have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and liraglutide use in humans.

Pancreatitis

It may also cause inflammation of the pancreas (pancreatitis). Stop using Saxenda and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your waist to your back. On spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with liraglutide.

Gallbladder Disease

Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was more significant in Saxenda-treated patients than in placebo-treated patients even after accounting for the degree of weight loss.

Hypoglycemia

Adult patients with type 2 diabetes mellitus on an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia using Saxenda, including severe hypoglycemia. The risk of hypoglycemia may be lowered by reducing the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin.

Increase in Heart Rate

Mean increases in resting heart rate of 2 to 3 beats per minute (bpm) were observed with routine clinical monitoring in Saxenda- treated adult patients compared to placebo in clinical trials. In a clinical pharmacology trial that monitored heart rate continuously for 24 hours, Saxenda treatment was associated with a heart rate that was 4 to 9 bpm higher than that observed with a placebo.

Renal Impairment

In patients treated with GLP-1 receptor agonists, including Saxenda, reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis. Altered renal function has been reversed in many reported cases with supportive treatment and discontinuation of potentially causative agents, including liraglutide.

Hypersensitivity Reactions

There have been reports of severe hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with liraglutide. If a hypersensitivity reaction occurs, you should discontinue Saxenda and other suspect medications and promptly seek medical advice.

Suicidal Behavior and Ideation

In Saxenda adult clinical trials, 9 (0.3%) of 3384 Saxenda- treated patients and 2 (0.1%) of the 1941 placebo-treated patients reported suicidal ideation; one of these Saxenda-treated patients attempted suicide. Monitor for the emergence or worsening of depression, suicidal thoughts or behavior, and any unusual changes in mood or behavior. Please discontinue medication if you experience suicidal thoughts or behaviors. Avoid any medicines in patients with a history of suicidal attempts or active suicidal ideation.

Allergic Reactions

Please tell your doctor about any allergies. 

The active ingredient in this medication is liraglutide. The inactive ingredients are disodium phosphate dihydrate, propylene glycol, phenol, and water for injection.

Usage

Once a day, Saxenda is usually administered. Make sure you follow all directions on your prescription label. There may be times when your doctor changes your dose. It is not recommended that you take this medicine in larger or smaller amounts or for longer than recommended.

Saxenda and Victoza should not be used together. It is not recommended to use these two brands together since they contain the same active ingredient.

Make sure you read all patient information, medication guides, and instruction sheets. If you have any questions, ask your doctor or pharmacist.

With or without a meal, Saxenda can be injected under the skin at any time of day. Injections will be demonstrated at home. Self-injecting this medicine is not recommended if you do not know how to give the injection and how to safely dispose of used needles and syringes.

Prefilled injection pens are available for Saxenda. You should ask your pharmacist what type of needles are best for your pen.

Saxenda should be injected in the best places on your body as determined by your healthcare provider. Every time you give an injection, use a different place. Injecting into the same place twice is not recommended.

Saxenda- Self Injectable

Saxenda should not be used if it has changed colors or if it contains particles. If you need new medicine, contact your pharmacist.

Hyperglycemia can also cause increased thirst or urination, blurred vision, headaches, and fatigue.

An individual’s blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Consult your doctor before changing your medication schedule or dose.

As part of a complete treatment program, Saxenda may also be used in conjunction with diet, exercise, weight control, regular blood sugar testing, and special medical care. Make sure you follow your doctor’s instructions carefully.

Dosing

To reduce the likelihood of gastrointestinal symptoms, dose escalation may be delayed by 1 additional week if necessary:

  1. Week 1: Inject 0.6 mg under the skin once a day
  2. Week 2: Inject 1.2 mg under the skin once a day
  3. Week 3: Inject 1.8 mg under the skin once a day
  4. Week 4: Inject 2.4 mg under the skin once a day
  5. Week 5: Inject 3 mg under the skin once a day

 

Maintenance dose: 3 mg subcutaneously once a day.

Saxenda Dosage

Discontinuation is recommended if the maintenance dose is not tolerated; lower doses have not been proven effective for chronic weight management.

Combining Saxenda with any other GLP-1 receptor agonist is not recommended. Saxenda has not been tested in combination with other weight loss products, such as prescription drugs, over-the-counter medications, and herbal preparations.

It is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment. This is because 4% or more of body weight has not been lost at 16 weeks.For chronic weight management in patients with an initial BMI of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) who have at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes, or dyslipidemia) in addition to a reduced-calorie diet and increased physical activity.

The Body Mass Index is calculated by dividing the weight in kilograms by the height in meters squared. Various charts are available for determining BMI based on height and weight, including one on the Saxenda product label.

Overdose

Overdoses have been reported in clinical trials and post-marketing use of liraglutide. Effects have included severe nausea, severe vomiting, and severe hypoglycemia. In the event of overdosage, appropriate supportive treatment should be initiated and, if needed, visit the nearest health facility. 

The use of liraglutide post-marketing and in clinical trials has been associated with overdoses. Severe nausea and vomiting have been reported as side effects. The patient’s clinical signs and symptoms should be monitored in the event of overdosage.

Drug Interactions

250 drugs interact with Saxenda (liraglutide), including 2 major interactions, 222 moderate interactions, and 26 minor interactions. The two major are: bexarotene and  gatifloxacin.

When you take Saxenda, your body may take longer to absorb any medicines you take by mouth.

If you start or stop taking any medicines, especially insulin or oral diabetes medicines (Glucotrol, Metaglip, Amaryl, Avandaryl, Duetact, DiaBeta, Micronase, Glucovance, etc.) tell your doctor.

There are some items that are not included in this list. Prescription and over-the-counter medicines, vitamins, and herbal products may interact with liraglutide. This tab does not list all possible interactions.

Pregnancy

Saxenda is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. There are no available data with liraglutide in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Saxenda should not be used during pregnancy. 

This drug was excreted into rat milk at approximately 50% of maternal plasma concentrations in animal studies. In rats treated with this drug during gestation and lactation, postnatal weight gain was reduced. There may be a link between this finding and reduced maternal food consumption.

In consideration of the importance of the drug to the mother, a decision should be made whether to discontinue breastfeeding or discontinue the drug.

Storage

Store new, unused Saxenda pens in the refrigerator between 36°F and 46°F (2°C to 8°C). After first use, store in a refrigerator or at room temperature between 59°F and 86°F (15°C to 30°C).

Don’t freeze Saxenda. Saxenda that has been frozen must not be used.

Pens in use should be thrown away after 30 days even if they still have Saxenda left in them. 

Disposing

Please do not throw away in the household trash. As soon as possible after using a Saxenda pen, dispose of the needle and any empty Saxenda pen or pen still containing Saxenda in a FDA-cleared sharps disposal container.

If you do not have a FDA-cleared sharps disposal container, you can choose a household container if it is made of a heavy-duty plastic or can be closed with a tight-fitting, puncture-resistant lid, preventing sharps from falling out upright and stable during use, leak-resistant, properly labeled to warn of hazardous waste inside the container.

If your sharps disposal container is almost full, you will need to follow your community’s guidelines for how to dispose of it. State or local laws may govern how you should dispose of used needles and syringes. Visit the FDA’s website at: http://www.fda.gov/safesharpsdisposal for more information about safe sharps disposal and for state-specific information about sharps disposal.

Unless your community guidelines permit it, do not dispose of your used sharps disposal container in your household trash. Your used sharps disposal container should not be recycled.

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