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Waylis Therapeutics is committed to providing continuous access to therapy and have allocated significant resources to create a wide-scale patient access program to reduce overall patient out-of-pocket costs for HYDREA^®.

Terms and conditions apply. Call Waylis Patient Access and Affordability for full details.

For Patients with Commercial Insurance

Commercially insured patients may pay as little as $10 for their prescription. Information for the pharmacist here:

HYDREA® Copay Card

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BIN #: 610600
PCN#: AS
RxGroup: 389
ID#: 38900958554

For Patients with Medicare, Medicaid, or TRICARE

Medicare, Medicaid, or TRICARE insured patients, as well as patients without insurance may qualify to get HYDREA® at no cost.

Fax: Fill out this PAP form (PDF) and fax it to Waylis Patient Access and Affordability at (844) 470-1931
Call: Waylis Patient Access and Affordability at (888) 218-8897 to get started.

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Indication & Safety Information for HYDREA®

CONTRAINDICATIONS

HYDREA® is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation.

ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

INDICATIONS AND USAGE

HYDREA is indicated for the treatment of:

Resistant chronic myeloid leukemia.
Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation.

WARNINGS & PRECAUTIONS

Myelosuppression

Hydroxyurea causes severe myelosuppression. Treatment with HYDREA should not be initiated if bone marrow function is markedly depressed. Bone marrow suppression may occur, and leukopenia is generally its first and most common manifestation. Thrombocytopenia and anemia occur less often and are seldom seen without a preceding leukopenia. Bone marrow depression is more likely in patients who have previously received radiotherapy or cytotoxic cancer chemotherapeutic agents; use HYDREA cautiously in such patients.

Evaluate hematologic status prior to and during treatment with HYDREA. Provide supportive care and modify dose or discontinue HYDREA as needed. Recovery from myelosuppression is usually rapid when therapy is interrupted.

Hemolytic Anemia

Cases of hemolytic anemia in patients treated with HYDREA for myeloproliferative diseases have been reported [see Adverse Reactions (6.1)]. Patients who develop acute jaundice or hematuria in the presence of persistent or worsening of anemia should have laboratory tests evaluated for hemolysis (e.g., measurement of serum lactate dehydrogenase, haptoglobin, reticulocyte, unconjugated bilirubin levels, urinalysis, and direct and indirect antiglobulin [Coombs] tests). In the setting of confirmed diagnosis of hemolytic anemia and in the absence of other causes, discontinue HYDREA.

Malignancies

Hydroxyurea is a human carcinogen. In patients receiving long-term hydroxyurea for myeloproliferative disorders, secondary leukemia has been reported. Skin cancer has also been reported in patients receiving long-term hydroxyurea. Advise protection from sun exposure and monitor for the development of secondary malignancies.

Embryo-Fetal Toxicity

Based on the mechanism of action and findings in animals, HYDREA can cause fetal harm when administered to a pregnant woman. Hydroxyurea was embryotoxic and teratogenic in rats and rabbits at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose on a mg/m² basis. Advise pregnant women of the potential risk to a fetus [see Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception during and after treatment with HYDREA for at least 6 months after therapy. Advise males of reproductive potential to use effective contraception during and after treatment with HYDREA for at least 1 year after therapy [see Use in Specific Populations (8.1, 8.3)].

Vasculitic Toxicities

Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxyurea. These vasculitic toxicities were reported most often in patients with a history of, or currently receiving, interferon therapy. If cutaneous vasculitic ulcers occur, institute treatment and discontinue HYDREA.

Live Vaccinations

Avoid use of live vaccine in patients taking HYDREA. Concomitant use of HYDREA with a live virus vaccine may potentiate the replication of the virus and/or may increase the adverse reaction of the vaccine because normal defense mechanisms may be suppressed by HYDREA. Vaccination with live vaccines in a patient receiving HYDREA may result in severe infection. Patient's antibody response to vaccines may be decreased. Consider consultation with a specialist.

Risks with Concomitant Use of Antiretroviral Drugs

Pancreatitis, hepatotoxicity, and peripheral neuropathy have occurred when hydroxyurea was administered concomitantly with antiretroviral drugs, including didanosine and stavudine [see Drug Interactions (7.1)].

Radiation Recall

Patients who have received irradiation therapy in the past may have an exacerbation of post-irradiation erythema. Monitor for skin erythema in patients who previously received radiation and manage symptomatically.

Macrocytosis

HYDREA may cause macrocytosis, which is self-limiting, and is often seen early in the course of treatment. The morphologic change resembles pernicious anemia, but is not related to vitamin B12 or folic acid deficiency. This may mask the diagnosis of pernicious anemia. Prophylactic administration of folic acid is recommended.

Pulmonary Toxicity

Interstitial lung disease including pulmonary fibrosis, lung infiltration, pneumonitis, and alveolitis/allergic alveolitis (including fatal cases) have been reported in patients treated for myeloproliferative neoplasm. Monitor patients developing pyrexia, cough, dyspnea, or other respiratory symptoms frequently, investigate and treat promptly. Discontinue HYDREA and manage with corticosteroids [see Adverse Reactions (6.1)].

Laboratory Test Interference

Interference with Uric Acid, Urea, or Lactic Acid Assays is possible, rendering falsely elevated results of these in patients treated with hydroxyurea [see Drug Interactions (7.2)].

Hydroxyurea may falsely elevate sensor glucose results from certain continuous glucose monitoring (CGM) systems and may lead to hypoglycemia if sensor glucose results are relied upon to dose insulin.

If a patient using a CGM is to be prescribed hydroxyurea, consult with the CGM prescriber about alternative glucose monitoring methods [see Drug Interactions (7.2)].

CONTRAINDICATIONS

HYDREA is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation.

ADVERSE REACTIONS

Most common adverse reactions (≥30%) are hematological, gastrointestinal symptoms, and anorexia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary

HYDREA can cause fetal harm based on findings from animal studies and the drug's mechanism of action [see Clinical Pharmacology (12.1)]. There are no data with HYDREA use in pregnant women to inform a drug-associated risk. In animal reproduction studies, administration of hydroxyurea to pregnant rats and rabbits during organogenesis produced embryotoxic and teratogenic effects at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose on a mg/m2 basis (see Data). Advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with HYDREA.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively.

Data

Animal Data

Hydroxyurea has been demonstrated to be a potent teratogen in a wide variety of animal models, including mice, hamsters, cats, miniature swine, dogs, and monkeys at doses within 1-fold of the human dose given on a mg/m² basis. Hydroxyurea is embryotoxic and causes fetal malformations (partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, missing lumbar vertebrae) at 180 mg/kg/day (about 0.8 times the maximum recommended human daily dose on a mg/m² basis) in rats and at 30 mg/kg/day (about 0.3 times the maximum recommended human daily dose on a mg/m2 basis) in rabbits. Embryotoxicity was characterized by decreased fetal viability, reduced live litter sizes, and developmental delays. Hydroxyurea crosses the placenta. Single doses of ≥375 mg/kg (about 1.7 times the maximum recommended human daily dose on a mg/m2 basis) to rats caused growth retardation and impaired learning ability.

Lactation

Risk Summary

Hydroxyurea is excreted in human milk. Because of the potential for serious adverse reactions in a breastfed infant from hydroxyurea, including carcinogenicity, discontinue breastfeeding during treatment with HYDREA.

Females and Males of Reproductive Potential

Pregnancy Testing

Verify the pregnancy status of females of reproductive potential prior to initiating HYDREA therapy.

Contraception

Females

HYDREA can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during and after treatment with HYDREA for at least 6 months after therapy. Advise females to immediately report pregnancy.

Males

HYDREA may damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities. Males with female sexual partners of reproductive potential should use effective contraception during and after treatment with HYDREA for at least 1 year after therapy [see Nonclinical Toxicology (13.1)].

Infertility

Males

Based on findings in animals and humans, male fertility may be compromised by treatment with HYDREA. Azoospermia or oligospermia, sometimes reversible, has been observed in men. Inform male patients about the possibility of sperm conservation before the start of therapy [see Adverse Reactions (6) and Nonclinical Toxicology (13.1)].

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Elderly patients may be more sensitive to the effects of hydroxyurea and may require a lower dose regimen. Hydroxyurea is excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration (2.3)].

Renal Impairment

The exposure to hydroxyurea is higher in patients with creatinine clearance of less than 60 mL/min or in patients with end-stage renal disease (ESRD). Reduce dosage and closely monitor the hematologic parameters when HYDREA is to be administered to these patients [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].

Hepatic Impairment

There are no data that support specific guidance for dosage adjustment in patients with hepatic impairment. Close monitoring of hematologic parameters is advised in these patients.

PATIENT COUNSELING INFORMATION

There is a risk of myelosuppression. Monitoring blood counts weekly throughout the duration of therapy should be emphasized to patients taking HYDREA. Advise patients to report signs and symptoms of infection or bleeding immediately [see Warnings and Precautions (5.1)].
Advise patients of the risk of hemolytic anemia. Advise patients that they will have blood tests to evaluate for this if they develop persistent anemia [see Warnings and Precautions (5.2)].
Advise patients that there is a risk of cutaneous vasculitic toxicities and secondary malignancies including leukemia and skin cancers [see Warnings and Precautions (5.3, 5.5)].
Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Advise females and males of reproductive potential to use contraception during and after treatment with HYDREA [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1, 8.3)].
Advise patients to inform their healthcare provider if they have received or are planning to receive vaccinations while taking HYDREA as this may result in a severe infection [see Warnings and Precautions (5.6)].
Advise females to discontinue breastfeeding during treatment with HYDREA [see Use in Specific Populations (8.2)].
Patients with HIV infection should contact their physician for signs and symptoms of pancreatitis, hepatic events, and peripheral neuropathy [see Warnings and Precautions (5.7)].
Post-irradiation erythema can occur in patients who have received previous irradiation therapy [see Warnings and Precautions (5.8)].
Advise patients of the symptoms of potential pulmonary toxicity and instruct them to seek prompt medical attention in the event of pyrexia, cough, dyspnea, or other respiratory symptoms [see Warnings and Precautions (5.10)].
Advise patients to notify their healthcare provider if they are using a continuous glucose monitoring system while taking HYDREA [see Warnings and Precautions (5.11)].

Waylis Therapeutics is committed to providing continuous access to therapy and have allocated significant resources to create a wide-scale patient access program to reduce overall patient out-of-pocket costs for HYDREA®.

For Patients with Commercial Insurance

HYDREA® Copay Card

For Patients with Medicare, Medicaid, or TRICARE

Indication & Safety Information for HYDREA®

CONTRAINDICATIONS

ADVERSE REACTIONS

IMPORTANT SAFETY INFORMATION AND INDICATIONS

INDICATIONS AND USAGE

WARNINGS & PRECAUTIONS

Myelosuppression

Hemolytic Anemia

Malignancies

Embryo-Fetal Toxicity

Vasculitic Toxicities

Live Vaccinations

Risks with Concomitant Use of Antiretroviral Drugs

Radiation Recall

Macrocytosis

Pulmonary Toxicity

Laboratory Test Interference

CONTRAINDICATIONS

ADVERSE REACTIONS

USE IN SPECIFIC POPULATIONS

Pregnancy

Lactation

Females and Males of Reproductive Potential

Pediatric Use

Geriatric Use

Renal Impairment

Hepatic Impairment

PATIENT COUNSELING INFORMATION

Waylis Therapeutics is committed to providing continuous access to therapy and have allocated significant resources to create a wide-scale patient access program to reduce overall patient out-of-pocket costs for HYDREA^®.