FAQs for HCPs | IncyteCARES for ZYNYZ®
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IncyteCARES is a program for residents 
of the United States and Puerto Rico.

For Patients

About IncyteCARES

IncyteCARES is a program to help your eligible patients start and stay on therapy with ZYNYZ® (retifanlimab-dlwr) by assisting with access and as-needed support.

IncyteCARES offers an array of services and programs to Healthcare Professionals and their patients prescribed ZYNYZ, which may include:

  • Benefits verification for ZYNYZ
  • Prescription drug coverage guidance for patients
  • Information about savings and financial support options, such as the:
    • IncyteCARES Savings Program, which allows eligible patients with commercial prescription drug coverage to pay as little as $15 per month for their ZYNYZ, subject to certain limits
    • Patient Assistance Program, which provides free medication for eligible patients who do not have prescription drug insurance or have trouble affording their out-of-pocket costs for ZYNYZ. No purchase contingencies or other obligations apply
  • Education and support resources, including symptom tracking tools
  • Information about organizations or independent foundations that may be able to assist with treatment-related costs, counseling, support groups, and more
  • ICD-10-CM codes for ZYNYZ
  • Sample Letter of Medical Necessity, Letter of Appeal, and Medical Exception templates for your use to help address insurer coverage denials

You can enroll your patient by completing an IncyteCARES enrollment form, which can also serve as your patient’s prescription for ZYNYZ. You can download and fax the IncyteCARES Program Enrollment Form PDF. Note that not all patients who are prescribed ZYNYZ are eligible for enrollment or for all services we provide. Contact us at 1-855-452-5234 for more information.

A patient can call IncyteCARES themselves to start the enrollment process. In that case, an IncyteCARES team member will reach out to the provider to get some of the information necessary for completing enrollment.

Yes, any patient who has been prescribed ZYNYZ can enroll in IncyteCARES but may not be eligible to receive some of the services or support we offer. Contact IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET
for more information.

If you are requesting only a benefits investigation for ZYNYZ, your patient’s signature on the enrollment form is not necessary. If you are enrolling your eligible patient in IncyteCARES for our other services to support their treatment with ZYNYZ, the patient’s or the patient’s legal guardian’s authorization is required. If neither is available to sign an enrollment form with you, you can submit it without the signature and IncyteCARES will call the patient or legal guardian to request a verbal authorization.

Yes, you can enroll a patient in IncyteCARES while waiting for insurance approval. In fact, once your patient is enrolled, the IncyteCARES team can assist with benefits verification or provide support in the event that coverage is denied.

Call us at 1-855-452-5234. Our IncyteCARES team is available Monday through Friday, 8 AM–8 PM ET.

Benefits Investigation

Yes, IncyteCARES can assist with benefits verification for enrolled patients. We can contact the insurer to get information about the patient’s coverage, out-of-pocket costs, and any special requirements, such as prior authorization. We will provide this information to both you and your patient.

We can complete most benefit verifications within 3 business days. If we encounter a delay, we will notify you and your patient within that time period.

If a patient’s insurer denies coverage, IncyteCARES will provide information to Healthcare Professionals and patients about filing an appeal. Our team will monitor the appeal process and facilitate communication with the insurance company. If the appeal is delayed or unsuccessful, IncyteCARES will assess the patient’s eligibility to receive the medication free of charge.

If a patient’s insurance changes during treatment, they should call IncyteCARES at 1-855-452-5234. We can determine any changes in their coverage or their out-of-pocket costs.

Savings Program

Yes, IncyteCARES offers a Savings Program for eligible patients with commercial prescription drug coverage. Patients enrolled in the Savings Program can receive their medication for as little as $15 per month, subject to certain limits.*

*Uninsured, cash-paying, or Alternate Funding Program (AFP) patients are not eligible. Not valid for patients insured through Medicare Part B, Medicare Advantage, Medicaid, TRICARE, or any state medical or pharmaceutical assistance program. Patient enrollment in a copay adjustment program, such as a maximizer or accumulator program, may impact the value of this offer. Annual benefit maximum applies, as may other restrictions. Program benefit applies to medication cost only and does not cover any costs to administer the medication. Valid prescription for ZYNYZ® (retifanlimab-dlwr) for an FDA-approved indication or compendia-recognized use is required. Please see the full Patient Terms and Conditions or call IncyteCARES for ZYNYZ at 1-855-452-5234. Update effective as of January 1, 2024.

To qualify, patients must:

  • Have commercial prescription drug coverage. Patients insured under federal or state government prescription drug programs—including Medicare Part B or D, Medicare Advantage, Medicaid, or TRICARE—are not eligible. Patients without prescription drug coverage are also not eligible
  • Be a resident of the United States or Puerto Rico
  • Have a valid prescription for ZYNYZ for an FDA-approved use

Enrolled patients pay as little as $15 for their prescription, subject to certain limits. See the complete terms and conditions.

When your patient is enrolled in IncyteCARES, our team immediately enrolls that patient in the Savings Program if they are eligible. Another option is to enroll an eligible patient for the Savings Program yourself at IncyteCARESsavings.ZYNYZ.com. Either way, a program member number is immediately issued and can be used right away. We will also mail your patient a welcome letter that shows their member number. Your patient does not need to be enrolled in IncyteCARES to access the Savings Program.

No. The patient’s enrollment in the Savings Program will automatically renew each year. However, they should contact IncyteCARES if their prescription insurance changes, so we can update their information and confirm that they are still covered.

Patient Assistance Program

Patients who have Medicare Part B but no Medicare Supplement (Medigap) coverage may be eligible to receive ZYNYZ free of charge through the IncyteCARES Patient Assistance Program as long as they meet household income requirements and other criteria.* This program helps eligible patients who are uninsured or underinsured and need help affording the out-of-pocket cost for their medication. Call IncyteCARES at 1-855-452-5234, Monday through Friday, 8 AM–8 PM ET to find out more.

*Terms and conditions apply. Terms of this program may change at any time.

To qualify for the Patient Assistance Program (PAP),* patients must:

  • Be confirmed as eligible for and enrolled in IncyteCARES
  • Be a resident of the United States or Puerto Rico
  • Have a valid prescription for ZYNYZ for an FDA-approved use
  • Meet one of these 3 criteria:

Uninsured

    1. Have no prescription drug coverage and meet household income criteria

Underinsured†

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    2. Have Medicare Part B, Medicare Part D, or Medicare Advantage and meet household income criteria
    3. Have any other type of health insurance (commercial, Medicaid, etc) but have exhausted or been denied coverage for ZYNYZ and meet household income criteria

*Terms and conditions apply. Terms of this program may change at any time.

†Patients who are enrolled in an Alternate Funding Program (AFP) are not eligible to receive free drug.

Once we receive the completed enrollment form, we can provide conditional approval within 3 business days. If we encounter a delay, we will notify you and your patient within that time period.

We provide conditional approval for the program, lasting up to 90 days, based on the patient’s enrollment form information. During this period, the patient must provide their income documentation to IncyteCARES before they can receive full approval for the PAP.

Acceptable documents for supporting current household income include the patient’s most current tax return, W-2 earnings statements, or one month of recent pay stubs.

Education and Support

Through our call center, our representatives can answer patients’ questions about ZYNYZ, their coverage, and basic questions about squamous cell carcinoma of the anal canal (SCAC) or Merkel cell carcinoma (MCC). We make it clear that we don’t provide medical advice and that the information we provide does not replace any provided by their Healthcare Professionals.

IncyteCARES itself does not offer this kind of support; however, we share information about certain nonprofit organizations that may be able to assist with medical-related travel or transportation expenses. Patient eligibility would be determined by the organization.

We can connect patients to nonprofit organizations that provide social and emotional support as well as information about other counseling services and support groups in their areas. Please contact us for current information about these support services. In some cases, Incyte provides grants or funding to certain organizations so that programs or activities are offered to patients free of charge.

 
 
IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Important immune-mediated adverse reactions listed may not be inclusive of all possible severe and fatal immune-mediated reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can occur at any time after starting or discontinuing treatment with a PD-1/PD-L1–blocking antibody, and can affect more than one body system simultaneously.

Monitor patients closely for symptoms and signs that may be clinical manifestations of such reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of PD-1/PD-L1–blocking antibodies. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. If

INDICATIONS AND USAGE

Squamous Cell Carcinoma of the Anal Canal

ZYNYZ, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).

ZYNYZ, as a single agent, is indicated for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.

Merkel Cell Carcinoma

ZYNYZ is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

suspected, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Monitor patients closely for symptoms and signs that may be clinical manifestations of such reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of PD-1/PD-L1–blocking antibodies. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. If suspected, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue ZYNYZ depending on severity. In general, if ZYNYZ requires interruption or discontinuation, administer systemic corticosteroid therapy (1-2 mg/kg/day prednisone or equivalent) until improvement to ≤ Grade 1. Then, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroids.

Immune-Mediated Pneumonitis

ZYNYZ can cause immune-mediated pneumonitis. Immune-mediated pneumonitis occurred in 3.1% (14/452) of patients, including 1 (0.2%) patient with fatal pneumonitis, Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Pneumonitis led to permanent discontinuation of ZYNYZ in 1 patient and withholding in 1.1%.

Systemic corticosteroids were required in 71% (10/14) of patients. Pneumonitis resolved in 11 of the 14 patients.

Immune-Mediated Colitis

ZYNYZ can cause immune-mediated colitis. Cytomegalovirus infections/reactivations have occurred in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1–blocking antibodies. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.

ZYNYZ as a Single Agent: Immune-mediated colitis occurred in 2.7% (12/452) of patients, including Grade 4 (0.2%), Grade 3 (0.4%), and Grade 2 (1.1%). Colitis led to permanent discontinuation of ZYNYZ in 0.9% of patients and withholding in 1.3%. Systemic corticosteroids were required in 75% (9/12) of patients. Colitis resolved in 8/12 patients.

ZYNYZ in Combination with Carboplatin and Paclitaxel: Immune-mediated colitis occurred in 10% (16/154) of patients receiving ZYNYZ in combination with carboplatin and paclitaxel, including Grade 4 (0.6%), Grade 3 (2.6%), and Grade 2 (3.2%). Colitis led to permanent discontinuation of ZYNYZ in 2 patients and withholding of ZYNYZ in 2 patients. Systemic corticosteroids were required in 94% (15/16) of patients. Colitis resolved in 15 of the 16 patients.

Immune-Mediated Hepatitis

ZYNYZ can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 3.5% (16/452) of patients, including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (0.9%). Hepatitis led to permanent discontinuation of ZYNYZ in 1.5% of patients and withholding in 1.1%.

Systemic corticosteroids were required in 81% (13/16) of patients. Hepatitis resolved in 9/16 patients.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

ZYNYZ can cause primary or secondary adrenal insufficiency. For ≥ Grade 2 adrenal insufficiency, initiate symptomatic treatment per institutional guidelines, including hormone replacement as clinically indicated. Withhold or permanently discontinue ZYNYZ depending on severity.

ZYNYZ as a Single Agent: Adrenal insufficiency occurred in 0.9% (4/452) of patients, including Grade 3 (0.4%) and Grade 2 (0.4%). ZYNYZ was permanently discontinued in no patients and was withheld for 1 patient with adrenal insufficiency. All patients required systemic corticosteroids. Adrenal insufficiency resolved in 1 of the 4 patients.

ZYNYZ in Combination with Carboplatin and Paclitaxel: Adrenal insufficiency occurred in 5.8% (9/154) of patients receiving ZYNYZ in combination with carboplatin and paclitaxel, including Grade 3 and Grade 2 (1.9% each). Adrenal insufficiency led to permanent discontinuation of ZYNYZ in 1 patient and withholding of ZYNYZ in 3 patients. All patients required systemic corticosteroids. Adrenal insufficiency resolved in 4 of the 9 patients.

Hypophysitis

ZYNYZ can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts, and can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue ZYNYZ depending on severity.

Hypophysitis occurred in 0.7% (3/452) of patients receiving ZYNYZ, including Grade 3 (0.2%) and Grade 2 (0.4%). Hypophysitis led to permanent discontinuation of ZYNYZ in 1 patient and withholding of ZYNYZ in 1 patient.

All patients required systemic steroids. Hypophysitis resolved in 1 of the 3 patients.

Thyroid Disorders

ZYNYZ can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement or medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue ZYNYZ depending on severity.

Thyroiditis occurred in 0.7% (3/452, all Grade 1) of patients. No patients discontinued or withheld ZYNYZ due to thyroiditis. Thyroiditis resolved in 1 of the 3 patients.

Hypothyroidism

Hypothyroidism occurred in 10% (46/452) of patients receiving ZYNYZ, including Grade 2 (4.9%). No patients discontinued due to hypothyroidism. ZYNYZ was withheld in 0.4% of patients.

Systemic corticosteroids were required for 1 patient, and 78% (36/46) of patients received endocrine therapy.

Hyperthyroidism

Hyperthyroidism occurred in 6% (26/452) of patients receiving ZYNYZ, including Grade 2 (2.7%). ZYNYZ was not discontinued in any patient and was withheld in 0.4% of patients. Systemic corticosteroids were required for 15% (4/26) of patients, and 50% (13/26) of patients received endocrine therapy.

Type 1 Diabetes Mellitus, Which Can Present with Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold ZYNYZ depending on severity.

Type 1 diabetes mellitus occurred in 0.2% (1/452) of patients, including Grade 3 (0.2%).

Immune-Mediated Nephritis with Renal Dysfunction

ZYNYZ can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 2% (9/452) of patients receiving ZYNYZ, including Grade 4 (0.4%), Grade 3 (1.1%), and Grade 2 (0.4%). Nephritis led to permanent discontinuation of ZYNYZ in 1.1% of patients and withholding in 0.7% of patients.

Systemic corticosteroids were required in 67% (6/9) of patients. Nephritis resolved in 4/9 patients.

Immune-Mediated Dermatologic Adverse Reactions

ZYNYZ can cause immune-mediated rash or dermatitis. Bullous and exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with PD-1/PD-L1–blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Withhold or permanently discontinue ZYNYZ depending on severity.

Immune-mediated skin reactions occurred in 10% (43/452) of patients, including Grade 4 (0.2%), Grade 3 (1.1%) and Grade 2 (8%). Immune-mediated dermatologic adverse reactions led to permanent discontinuation of ZYNYZ in 0.7% of patients and withholding in 2.7% of patients.

Systemic corticosteroids were required in 33% (14/43) of patients. Immune-mediated dermatologic adverse reactions resolved in 72% (31/43) of patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of < 1% in 452 patients who received ZYNYZ or were reported with the use of other PD-1/PD-L1–blocking antibodies, including severe or fatal cases.

Cardiac/vascular: myocarditis, pericarditis, vasculitis

Gastrointestinal: pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis

Musculoskeletal: myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis, polymyalgia rheumatica

Neurological: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy

Ocular: uveitis, iritis, and other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.

Endocrine: hypoparathyroidism

Hematologic/Immune: hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection.

Other: Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap Syndrome, reported as the co-occurrence of either two or all three adverse reactions.

Infusion-Related Reactions

A severe infusion-related reaction (Grade 3) occurred in 5 (0.8%) of 606 patients receiving ZYNYZ. Monitor patients for signs and symptoms; interrupt or slow the rate of infusion or permanently discontinue ZYNYZ based on severity of reaction. Consider premedication with an antipyretic and/or an antihistamine for patients who have had previous systemic reactions to infusions of therapeutic proteins.

Complications of Allogeneic HSCT

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1–blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause), which may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1–blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

ZYNYZ can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus, resulting in fetal death. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 4 months after the last dose.

Lactation

Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the last dose.

Adverse Reactions

Metastatic or Recurrent Locally Advanced MCC: ZYNYZ as a Single Agent

The safety of ZYNYZ was evaluated in 107 patients with metastatic or recurrent locally advanced MCC.

Serious adverse reactions occurred in 26% of patients receiving ZYNYZ. The most frequent serious adverse reactions (≥ 2% of patients) were fatigue, arrhythmia, and pneumonitis.

Permanent discontinuation of ZYNYZ due to an adverse reaction occurred in 21% of patients. These included asthenia, colitis, demyelinating polyneuropathy, diarrhea, drug hypersensitivity, eosinophilic fasciitis, hepatitis, hypophysitis, increased transaminases, infusion-related reaction, pancreatitis, polyarthritis, radiculopathy, toxic epidermal necrolysis, and tubulointerstitial nephritis (1 patient each).

Dosage interruptions due to an adverse reaction occurred in 39% of patients. Adverse reactions or laboratory abnormalities that required dosage interruption in > 2% of patients were increased transaminases, increased lipase, increased amylase, and pyrexia.

The most common (≥ 10%) adverse reactions were musculoskeletal pain, fatigue, pruritus, diarrhea, rash, pyrexia, nausea, and constipation.

Inoperable Locally Recurrent or Metastatic SCAC: ZYNYZ in Combination with Carboplatin and Paclitaxel

The safety of ZYNYZ in patients with inoperable locally recurrent or metastatic SCAC was evaluated in 154 patients enrolled in the POD1UM-303 trial.

Serious adverse reactions occurred in 47% of patients receiving ZYNYZ in combination with carboplatin and paclitaxel. The most frequent serious adverse reactions (≥ 2% of patients) were sepsis (3.2%), pulmonary embolism (3.2%), diarrhea (2.6%), and vomiting (2.6%).

In patients receiving ZYNYZ in combination with carboplatin and paclitaxel, ZYNYZ was permanently discontinued due to an adverse reaction in 11% of patients. Adverse reactions that resulted in permanent discontinuation of ZYNYZ included immune-mediated enterocolitis (2 patients) and warm autoimmune hemolytic anemia, hepatitis, adrenal insufficiency, blood bilirubin increased, AST increased, blood alkaline phosphatase increased, arthritis, encephalopathy, peripheral sensorimotor neuropathy, hypothyroidism, immune-mediated cholangitis, pruritus, malaise, and rash (1 patient each).

Dosage interruptions due to an adverse reaction, excluding temporary interruptions due to infusion-related reactions, occurred in 55% of patients who received ZYNYZ in combination with carboplatin and paclitaxel. Adverse reactions that resulted in dosage interruptions in ≥ 2% of patients were neutropenia, anemia, thrombocytopenia, leukopenia, fatigue, COVID-19, and urinary tract infection.

The most common (≥ 20%) adverse reactions were fatigue, peripheral neuropathy, nausea, alopecia, diarrhea, musculoskeletal pain, constipation, hemorrhage, rash, vomiting, decreased appetite, pruritus, and abdominal pain.

Platinum-refractory Intolerant Locally Recurrent or Metastatic SCAC: ZYNYZ as a Single Agent

The safety of ZYNYZ in patients with platinum-refractory intolerant locally recurrent or metastatic SCAC was evaluated in 94 patients in the POD1UM-202 trial.

Serious adverse reactions occurred in 40% of patients receiving ZYNYZ. The most frequent serious adverse reactions (≥ 2% of patients) were non-urinary tract infection, perineal pain, abdominal pain, anemia, hemorrhage, diarrhea, pyrexia, urinary tract infection, musculoskeletal pain, and dyspnea.

Permanent discontinuation of ZYNYZ due to an adverse reaction occurred in 4.3% of patients. These adverse reactions included diarrhea, non-urinary tract infection, perineal pain, and rash.

Dosage interruptions due to an adverse reaction occurred in 21% of patients who received ZYNYZ. Adverse reactions that resulted in dose delay in ≥ 2% of patients who received ZYNYZ were non-urinary tract infection, rash, diarrhea, abdominal pain, hemorrhage, musculoskeletal pain, pyrexia, and urinary tract infection.

The most common (≥ 10%) adverse reactions that occurred in patients receiving ZYNYZ were fatigue, musculoskeletal pain, diarrhea, non-urinary tract infections, perineal pain, hemorrhage, urinary tract infection, rash, nausea, decreased appetite, constipation, abdominal pain, dyspnea, pyrexia, vomiting, cough, pruritus, hypothyroidism, headache, and decreased weight.

Please see the Full Prescribing Information.