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Pharmacy Bulletin 01-29-21

Pharmacy Bulletin 01-29-21

We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines.

VativoRx Bottle update

Cabenuva (cabotegravir, rilpivirine), Vocabria (cabotegravir) – New drug approvals

The FDA announced the approval of ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable ARV regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

Lupkynis™ (voclosporin) – New drug approval

Aurinia Pharmaceuticals announced the FDA approval of Lupkynis (voclosporin), in combination with a background immunosuppressive therapy regimen, for the treatment of adult patients with active lupus nephritis (LN).

Verquvo™ (vericiguat) – New drug approval

Merck announced the FDA approval of Verquvo (vericiguat), to reduce the risk of cardiovascular (CV) death and heart failure (HF) hospitalization following a hospitalization for HF or need for outpatient intravenous diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

Darzalex Faspro® (daratumumab/hyaluronidase-fihj) – New indication, expanded indication

Janssen announced the FDA approval of Darzalex Faspro (daratumumab/hyaluronidase-fihj), in combination with bortezomib, cyclophosphamide, and dexamethasone for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.

Enhertu® (fam-trastuzumab deruxtecan-nxki) – New indication

Daiichi Sankyo and AstraZeneca announced the FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki), for the treatment of adult patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

Opdivo® (nivolumab), Cabometyx® (cabozantinib) – Expanded indication

Bristol Myers Squibb and Exelixis announced the FDA approval of Opdivo (nivolumab) plus Cabometyx (cabozantinib), for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Xalkori® (crizotinib) – New indication

Pfizer announced the FDA approval of Xalkori (crizotinib), for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.

Zomig® (zolmitriptan) – First-time authorized brand alternative