XROMI 100 mg/mL
Hydroxyurea · SOLUTION · Nova Laboratories, Ltd.
Xromi is an oral solution containing hydroxyurea, an antimetabolite medication used to treat certain blood disorders and cancers. It comes as a liquid at a strength of 100 mg/mL and requires a prescription from your doctor.
Key Facts
- Brand Name
- XROMI
- Generic Name
- Hydroxyurea
- NDC Code (Product)
62484-0015- Manufacturer
- Nova Laboratories, Ltd.
- Strength
- 100 mg/mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA216593
- Drug Class
- Antimetabolite [EPC]
- Marketing Start
- 04/04/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE XROMI is indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age and older with sickle cell anemia with recurrent moderate to severe painful crises. XROMI is an antimetabolite indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age and older with sickle cell anemia with recurrent moderate to severe painful crises. (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Initial dose: 15 mg/kg orally once daily. Monitor the patient’s blood count every two weeks. (2.1) The dose may be increased by 5 mg/kg/day every 8 to 12 weeks until a maximum tolerated dose or 35 mg/kg/day is reached if blood counts are in an acceptable range. (2.1) The dose is not increased if blood counts are below the acceptable range and toxic. Discontinue XROMI until hematologic recovery if blood counts are considered toxic. Treatment may be resumed after reducing the dose by 2.5mg/kg/day to 5mg/kg/day from the dose associated with hematological toxicity. (2.1) Renal impairment: Reduce the dose of XROMI by 50% in patients with creatinine clearance less than 60 mL/min. (2.2 , 8.6 , 12.3) 2.1 Recommended Dosage The recommended XROMI dosage in pediatric patients aged 6 months and older is described in Table 1. Table 1. Dosing Recommendation Based on Blood Count Dosing Regimen Dose Dose modification criteria Monitoring parameters Initial Recommended dosing 15 mg/kg/day (rounded to nearest 10 mg) orally as a single dose once daily based on the patient’s actual body weight. Monitor the patient’s complete blood count (CBC) with differential and reticulocy…
Contraindications
4 CONTRAINDICATIONS XROMI is contraindicated in patients: who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. [see Adverse Reactions (6) ] . In patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. (4)
Drug Interactions
7 DRUG INTERACTIONS Antiretroviral drug. (7.1) Laboratory Test Interference. (7.2) 7.1 Increased Toxicity with Concomitant Use of Antiretroviral Drugs Pancreatitis In patients with HIV infection during therapy with hydroxyurea and didanosine, with or without stavudine, fatal and nonfatal cases of pancreatitis have occurred. Hydroxyurea is not indicated for the treatment of HIV infection; however, if patients with HIV infection are treated with hydroxyurea, and in particular, in combination with didanosine and/or stavudine, close monitoring for signs and symptoms of pancreatitis is recommended. Permanently discontinue therapy with hydroxyurea in patients who develop signs and symptoms of pancreatitis. Hepatotoxicity Hepatotoxicity and hepatic failure resulting in death have been reported during postmarketing surveillance in patients with HIV infection treated with hydroxyurea and other antiretroviral drugs. Fatal hepatic events were reported most often in patients treated with the combination of hydroxyurea, didanosine, and stavudine. Avoid this combination. Peripheral Neuropathy Peripheral neuropathy, which was severe in some cases, has been reported in patients with HIV infection …
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in detail in other labeling sections: Myelosuppression [see Warnings and Precautions (5.1) ] Hemolytic anemia [see Warnings and Precautions (5.2) ] Malignancies [see Warnings and Precautions (5.3) ] Vasculitic toxicities [see Warnings and Precautions (5.5) ] Live vaccinations [see Warnings and Precautions (5.6) Risks with concomitant use of antiretroviral drugs [see Warnings and Precautions (5.7) ] Macrocytosis [see Warnings and Precautions (5.8) ] Pulmonary toxicity [see Warnings and Precautions (5.9) ] Most common adverse reactions (incidence > 5%) are neutropenia and thrombocytopenia, and popular rash. (6) To report SUSPECTED ADVERSE REACTIONS, contact Rare Disease Therapeutics, Inc. at 844-472-7389 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of XROMI was evaluated in 32 pediatric pati…
Frequently Asked Questions
What is XROMI used for?
Xromi is an oral solution containing hydroxyurea, an antimetabolite medication used to treat certain blood disorders and cancers. It comes as a liquid at a strength of 100 mg/mL and requires a prescription from your doctor.
Is XROMI a controlled substance?
XROMI is not classified as a controlled substance by the DEA.
What is the generic name for XROMI?
The generic name for XROMI is Hydroxyurea. There are 11 other brand versions of Hydroxyurea.
What is the NDC code for XROMI 100 mg/mL?
The NDC (National Drug Code) for XROMI 100 mg/mL is 62484-0015, listed by Nova Laboratories, Ltd..