Strong CYP3A4/P-gp inducer that may decrease paliperidone exposure. Avoid during 3-month dosing interval if possible; consider paliperidone extended-release tablets if necessary.
Source: NLP:paliperidone palmitate
Paliperidone Palmitate Interactions
Brand names: Invega Hafyera
Route: Intramuscular
FDA Black Box Warning
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. INVEGA HAFYERA is not approved for use in patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. INVEGA HAFYERA is not approved for use in patients with dementia-related psychosis. ( 5.1 )
Contraindications
4 CONTRAINDICATIONS INVEGA HAFYERA is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the INVEGA HAFYERA formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone palmitate is converted to paliperidone, which is a metabolite of risperidone. Known hypersensitivity to paliperidone, risperidone, or to any excipients in INVEGA HAFYERA. ( 4 )
Pregnancy & Breastfeeding
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including INVEGA HAFYERA, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . Risk Summary Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations ) . Overall, available data from published epidemiologic studies of pregnant women exposed to paliperidone have not established a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . There are risks to the mother associated with untreated schizophrenia and with exposure to antipsychotics, including INVEGA HAFYERA during pregnancy (see Clinical Considerations ) . Paliperidone has been detected in plasma in adult subjects up to 18 months after a single-dose administration of 3-month paliperidone palmitate extended-release injectable suspension. [See Clinical Pharmacology (12.3) ] . The clinical significance of INVEGA HAFYERA administered before pregnancy or anytime during pregnancy is not known. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. In animal reproduction studies, there were no treatment related effects on the offspring when pregnant rats were injected intramuscularly with paliperidone palmitate or when pregnant rats and rabbits were treated or
9 interactions on record
Strong CYP3A4/P-gp inducer that may decrease paliperidone exposure. Avoid during 3-month dosing interval if possible; consider paliperidone extended-release tablets if necessary.
Source: NLP:paliperidone palmitate
Strong CYP3A4/P-gp inducer that may decrease paliperidone exposure. Avoid during 3-month dosing interval if possible; consider paliperidone extended-release tablets if necessary.
Source: NLP:paliperidone palmitate
Paliperidone Palmitate + AlcoholModerate
Concomitant use may modulate CNS effects of paliperidone palmitate. Use with caution.
Source: NLP:paliperidone palmitate
Concomitant use may modulate CNS effects of paliperidone palmitate. Use with caution.
Source: NLP:paliperidone palmitate
Paliperidone may antagonize the effects of dopamine agonists. Monitor and manage patient as clinically appropriate.
Source: NLP:paliperidone palmitate
Additive effect may occur with paliperidone palmitate's potential for inducing orthostatic hypotension. Monitor orthostatic vital signs.
Source: NLP:paliperidone palmitate
Paliperidone may antagonize the effect of levodopa. Monitor and manage patient as clinically appropriate.
Source: NLP:paliperidone palmitate
Concomitant use may decrease paliperidone exposure. Avoid during dosing interval if possible; consider paliperidone extended-release tablets if necessary.
Source: NLP:paliperidone palmitate