Siklos 100 mg/1
hydroxyurea · TABLET, FILM COATED · Medunik
Siklos is a tablet, film coated containing hydroxyurea at 100 mg/1, taken oral. Manufactured by Medunik.
Key Facts
- Brand Name
- Siklos
- Generic Name
- hydroxyurea
- NDC Code (Product)
71770-105- Manufacturer
- Medunik
- Strength
- 100 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA208843
- Drug Class
- Antimetabolite [EPC]
- Marketing Start
- 10/15/2020
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 SIKLOS ® is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises SIKLOS is an antimetabolite, indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric patients, 2 years 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 in adults and 20 mg/kg in children once daily. Monitor blood counts every two weeks. ( 2.1 ) The dose may be increased by 5 mg/kg/day every 8 weeks, or sooner if a severe painful crisis occurs, until a maximum tolerated dose or 35 mg/kg/day is reached if blood counts are in an acceptable range. ( 2.1 ) Discontinue SIKLOS until hematologic recovery if blood counts are considered toxic. Resume treatment after reducing the dose by 5 mg/kg/day from the dose associated with hematological toxicity. ( 2.1 ) Renal impairment: Reduce the dose of SIKLOS by 50% in patients with creatinine clearance less than 60 mL/min. ( 2.2 , 8.6 , 12.3 ) 2.1 Recommended Dosing The recommended SIKLOS dosing is described in Table 1. Table 1: Dosing Recommendation Based on Blood Count Dosing Regimen Dose Dose Modification Criteria Monitoring Parameters Initial Recommended Dosing Adults: 15 mg/kg Pediatrics: 20 mg/kg once daily based on patient's actual or ideal weight, whichever is less. Monitor the patient's blood count every 2 weeks [see Warnings and Precautions (5.1) ] . Dosing Adjustment Based on Blood Counts in an acceptable range Increase dose 5 mg/kg/da…
Contraindications
4 CONTRAINDICATIONS SIKLOS is contraindicated in: Patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation [see Adverse Reactions (6) ]. Patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Increased Toxicity with Concomitant Use of Antiretroviral Drugs Pancreatitis Pancreatitis (including fatal cases) have occurred in patients with HIV infection during therapy with hydroxyurea and didanosine, with or without stavudine. 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, monitor closely for signs and symptoms of pancreatitis. 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 receiving hydroxyurea in combination with antiretroviral drugs, including didanosine…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.2) ] Vasculitic toxicities (including Leg Ulcers) [see Warnings and Precautions (5.4) ] Risks with concomitant use of antiretroviral drugs [see Warnings and Precautions (5.5) ] Risk with concomitant use of live virus vaccine [see Warnings and Precautions (5.6) ] Macrocytosis [see Warnings and Precautions (5.7) ] Hemolytic Anemia [see Warnings and Precautions (5.9) ] Most common adverse reactions to SIKLOS (incidence > 10%) include infections and neutropenia in children and infections and headache and dry skin in adults. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact the marketer Medunik at 1 844-884-5520 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial 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 SIKLOS…
Frequently Asked Questions
What is Siklos used for?
Siklos contains hydroxyurea. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Siklos a controlled substance?
Siklos is not classified as a controlled substance by the DEA.
What is the generic name for Siklos?
The generic name for Siklos is hydroxyurea. There are 11 other brand versions of hydroxyurea.
What is the NDC code for Siklos 100 mg/1?
The NDC (National Drug Code) for Siklos 100 mg/1 is 71770-105, listed by Medunik.