DOCIVYX 80 mg/8mL
docetaxel · INJECTION, SOLUTION · Avyxa Pharma, LLC
DOCIVYX is a injection, solution containing docetaxel at 80 mg/8mL, taken intravenous. Manufactured by Avyxa Pharma, LLC.
Key Facts
- Brand Name
- DOCIVYX
- Generic Name
- docetaxel
- NDC Code (Product)
83831-102- Manufacturer
- Avyxa Pharma, LLC
- Strength
- 80 mg/8mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA215813
- Marketing Start
- 05/09/2024
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 DOCIVYX is a microtubule inhibitor indicated for: Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1 ) Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2 ) Castration- Resistant Prostate Cancer (CRPC) : with prednisone in metastatic CRPC ( 1.3 ) Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction ( 1.4 ) Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN ( 1.5 ) 1.1 Breast Cancer DOCIVYX is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. DOCIVYX in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. 1.2 Non-small Cell Lung Canc…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For all indications, toxicities may warrant dosage adjustments [see Dosage and Administration (2.7) ] . Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously (IV) over 1 hr every 3 weeks. PVC equipment is not recommended. Use only a 21-gauge needle to withdraw DOCIVYX from the vial. BC locally advanced or metastatic: 60 mg/m 2 to 100 mg/m 2 single agent ( 2.1 ) BC adjuvant: 75 mg/m 2 administered 1 hour after doxorubicin 50 mg/m 2 and cyclophosphamide 500 mg/m 2 every 3 weeks for 6 cycles ( 2.1 ) NSCLC: after platinum therapy failure: 75 mg/m 2 single agent ( 2.2 ) NSCLC: chemotherapy naive: 75 mg/m 2 followed by cisplatin 75 mg/m 2 ( 2.2 ) CRPC: 75 mg/m 2 with 5 mg prednisone twice a day continuously ( 2.3 ) GC: 75 mg/m 2 followed by cisplatin 75 mg/m 2 (both on day 1 only) followed by fluorouracil 750 mg/m 2 per day as a 24-hour IV (days 1-5), starting at end of cisplatin infusion ( 2.4 ) SCCHN: 75 mg/m 2 followed by cisplatin 75 mg/m 2 IV (day 1), followed by fluorouracil 750 mg/m 2 per day as a 24-hr IV (d…
Contraindications
4 CONTRAINDICATIONS DOCIVYX is contraindicated in patients with: neutrophil counts of <1500 cells/mm3 [see Warnings and Precautions (5.3) ]. a history of severe hypersensitivity reactions to docetaxel. Severe reactions, including anaphylaxis, have occurred [see Warnings and Precautions (5.5) ] . Hypersensitivity to docetaxel ( 4 ) Neutrophil counts of <1500 cells/mm 3 ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Docetaxel is a CYP3A4 substrate. In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4. In vivo studies showed that the exposure of docetaxel increased 2.2-fold when it was coadministered with ketoconazole, a potent inhibitor of CYP3A4. Protease inhibitors, particularly ritonavir, may increase the exposure of docetaxel. Concomitant use of DOCIVYX and drugs that inhibit CYP3A4 may increase exposure to docetaxel and should be avoided. In patients receiving treatment with DOCIVYX, close monitoring for toxicity and a DOCIVYX dose reduction could be considered if systemic administration of a potent CYP3A4 inhibitor cannot be avoided [see Dosage and Administration (2.7), Clinical Pharmacology (12.3) ]. Cytochrome P450 3A4 inducers, inhibitors, or substrates: May alter docetaxel metabolism. ( 7 )
Adverse Reactions
6 ADVERSE REACTIONS The most serious adverse reactions from DOCIVYX are: Toxic Deaths [see Boxed Warning , Warnings and Precautions (5.1) ] Hepatic Impairment [see Boxed Warning , Warnings and Precautions (5.2) ] Hematologic Effects [see Boxed Warning , Warnings and Precautions (5.3) ] Enterocolitis and Neutropenic Colitis [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Boxed Warning , Warnings and Precautions (5.5) ] Fluid Retention [see Boxed Warning , Warnings and Precautions (5.6) ] Second Primary Malignancies [see Warnings and Precautions (5.7) ] Cutaneous Reactions [see Warnings and Precautions (5.8) ] Neurologic Reactions [see Warnings and Precautions (5.9) ] Eye Disorders [see Warnings and Precautions (5.10)] Asthenia [see Warnings and Precautions (5.11) ] Alcohol Content [see Warnings and Precautions (5.13) ] The most common adverse reactions across all DOCIVYX indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia. Incide…
Frequently Asked Questions
What is DOCIVYX used for?
DOCIVYX contains docetaxel. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is DOCIVYX a controlled substance?
DOCIVYX is not classified as a controlled substance by the DEA.
What is the generic name for DOCIVYX?
The generic name for DOCIVYX is docetaxel. There are 11 other brand versions of docetaxel.
What is the NDC code for DOCIVYX 80 mg/8mL?
The NDC (National Drug Code) for DOCIVYX 80 mg/8mL is 83831-102, listed by Avyxa Pharma, LLC.