Hydroxyurea Interactions

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

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

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

Do not take for one month prior to mobilization or expected duration for elimination, and until all apheresis cycles completed.

Source: NLP:betibeglogene autotemcel

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

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

Drug associated with myelosuppression or nephrotoxicity. Consider coadministration only if potential benefits outweigh risks.

Source: NLP:valganciclovir