Avoid this combination. Fatal hepatic events and severe peripheral neuropathy reported most often with hydroxyurea, didanosine, and stavudine combination in HIV patients.
Source: NLP:hydroxyurea
Brand names: Hydrea
Antimetabolite
Route: Oral
FDA Black Box Warning
WARNING: MYELOSUPPRESSION and MALIGNANCIES Myelosuppression: XROMI may cause severe myelosuppression. Do not give if bone marrow function is markedly depressed. Monitor blood counts at baseline and throughout treatment. Interrupt treatment and reduce dose as necessary [see Warnings and Precautions(5.1) ] . Malignancies: Hydroxyurea is carcinogenic. Advise sun protection and monitor patients for malignancies [see Warnings and Precautions (5.3) ] . WARNING: MYELOSUPPRESSION and MALIGNANCIES See full prescribing information for complete boxed warning. Myelosuppression: XROMI may cause severe myelosuppression. Do not give if bone marrow function is markedly depressed. Monitor blood counts at baseline and throughout treatment. Interrupt treatment and reduce dose as necessary ( 5.1 ) . Malignancies Hydroxyurea is carcinogenic. Advise sun protection and monitor patients for malignancies ( 5.3 ).
Contraindications
4 CONTRAINDICATIONS HYDREA is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation. In patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. ( 4 )
Pregnancy & Breastfeeding
8.1 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/m 2 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/m 2 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/m 2 basis) in rats and at 30 mg/kg/day (about 0.3 times the maximum recommended human daily dose on a mg/m 2 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/m 2 basis) to rats caused growth retardation and impaired learning ability.
32 interactions on record
Avoid this combination. Fatal hepatic events and severe peripheral neuropathy reported most often with hydroxyurea, didanosine, and stavudine combination in HIV patients.
Source: NLP:hydroxyurea
Increased risk of methemoglobinemia when concurrently exposed to articaine.
Source: NLP:articaine hydrochloride and epinephrine
Increased risk of developing methemoglobinemia when concurrently exposed to this antineoplastic agent.
Source: NLP:articaine hydrochloride, epinephrine bitartrate
Increased risk of methemoglobinemia when concurrently exposed to this antineoplastic oxidizing agent with local anesthetics.
Source: NLP:benzocaine, butamben, and tetracaine hydrochloride
Increased risk of methemoglobinemia when concurrently exposed with bupivacaine.
Source: NLP:bupivacaine hydrochloride
Fatal and nonfatal pancreatitis has occurred in HIV patients receiving hydroxyurea with didanosine, with or without stavudine. Close monitoring for pancreatitis signs/symptoms is recommended.
Source: NLP:hydroxyurea
Associated with myelosuppression or nephrotoxicity; coadministration should be considered only if potential benefits outweigh risks.
Source: NLP:ganciclovir sodium
Increased risk of methemoglobinemia when used concurrently with lidocaine.
Source: NLP:lidocaine
Antineoplastic agent that may cause methemoglobinemia when used concomitantly with lidocaine patch 5%.
Source: NLP:lidocaine 5%
Antineoplastic agent that increases risk of methemoglobinemia when used concurrently with lidocaine and capsaicin patch.
Source: NLP:lidocaine and capsaicin
Antineoplastic agent; increased risk of methemoglobinemia when concurrently exposed.
Source: NLP:lidocaine and prilocaine
Increased risk of methemoglobinemia when used concurrently with lidocaine hydrochloride.
Source: NLP:lidocaine hydrochloride
Antineoplastic agent associated with increased methemoglobinemia risk when used concurrently.
Source: NLP:lidocaine hydrochloride and epinephrine bitartrate
Increased risk of methemoglobinemia when local anesthetic is concurrently exposed to antineoplastic agents.
Source: NLP:lidocaine hydrochloride and hydrocortisone acetate
Increased risk of methemoglobinemia when lidocaine is concurrently exposed to antineoplastic agents.
Source: NLP:lidocaine and menthol
Increased risk of methemoglobinemia when local anesthetics are concurrently exposed to antineoplastic agents.
Source: NLP:lidothol patch
Increased risk of methemoglobinemia when concurrently exposed to antineoplastic agents.
Source: NLP:marcaine, lidocaine, povidone iodine
Do not take for one month prior to mobilization or expected duration for elimination, and until all apheresis cycles completed.
Source: NLP:betibeglogene autotemcel
Concurrent exposure increases risk of methemoglobinemia in patients administered mepivacaine.
Source: NLP:mepivacaine hydrochloride
Increased risk of methemoglobinemia when prilocaine is concurrently exposed to hydroxyurea.
Source: NLP:prilocaine hcl and epinephrine
Increased risk of methemoglobinemia when used concurrently with prilocaine.
Source: NLP:prilocaine hydrochloride
Increased risk of developing methemoglobinemia when concurrently exposed to hydroxyurea.
Source: NLP:ropivacaine hydrochloride
Fatal and nonfatal pancreatitis, hepatotoxicity with hepatic failure, and severe peripheral neuropathy reported in HIV patients receiving hydroxyurea with stavudine, particularly in combination with didanosine.
Source: NLP:hydroxyurea
Increased risk of methemoglobinemia when concurrently exposed.
Source: NLP:bupivacaine hydrochloride, lidocaine hydrochloride, triamcinolone acetonide, povidine iodine
Co-administration with valganciclovir should be considered only if potential benefits outweigh risks due to potential for higher toxicity from myelosuppression or nephrotoxicity.
Source: NLP:valganciclovir hydrochloride
May increase risk of methemoglobinemia when concurrently exposed with bupivacaine.
Source: NLP:bupivacaine
Increased risk of methemoglobinemia when concurrently exposed.
Source: NLP:bupivacaine hydrochloride and epinephrine bitartrate
Associated with myelosuppression or nephrotoxicity. Coadministration considered only if benefits outweigh risks.
Source: NLP:ganciclovir
Antineoplastic agent that increases risk of methemoglobinemia when used concomitantly with lidocaine and tetracaine.
Source: NLP:lidocaine and tetracaine
Increased risk of methemoglobinemia when concurrently exposed to antineoplastic agents with bupivacaine.
Source: NLP:methylprednisolone acetate, bupivacaine hydrochloride, povidone-iodine
Increased risk of methemoglobinemia when concurrently exposed with local anesthetics (procaine is a component of this drug product).
Source: NLP:penicillin g benzathine and penicillin g procaine
Drug associated with myelosuppression or nephrotoxicity. Consider coadministration only if potential benefits outweigh risks.
Source: NLP:valganciclovir