Vinorelbine 10 mg/mL Injection, Solution, 1 vial
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Vinca Alkaloid class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Vinorelbine is used alone and in combination with other medications to treat non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body. Vinorelbine is in a class of medications called vinca alkaloids. It works by slowing or stopping the growth of cancer cells in your body.
Read the full MedlinePlus article ↗- Vinorelbine Injection is a chemotherapy used to treat non-small cell lung cancer (NSCLC) that has spread — either within the chest or to other parts of the body. Depending on your...
- What exactly is vinorelbine being used to treat?
- No, vinorelbine is always given by a nurse or other trained professional through an IV in a clinic, infusion center, or hospital. You can't take it at home. Each infusion takes abo...
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🧪 Inactive Ingredients / Excipients
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
1 inactive ingredient listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $18.78 | $18.78 / 1 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J9390 | $4.290 / J9390 unit | — |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Vinorelbine 10 mg/mLthis 45963-0607-55 | Actavis | 1 vial | — | AP | FDA listed | — |
| Vinorelbine 10 mg/mL 25021-0204-01 | Sagent | 1 vial | — | AP | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 45963-0607-55 You're viewing this | 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-55) / 1 mL in 1 VIAL, SINGLE-DOSE | 2015-03-01 | Active |
| 45963-0607-56 | 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-56) / 5 mL in 1 VIAL, SINGLE-DOSE | 2015-03-01 | Active |
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🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: MYELOSUPPRESSION Severe myelosuppression resulting in serious infection, septic shock, hospitalization and death can occur [see Warnings and Precautions (5.1) ]. Decrease the dose or withhold vinorelbine in accord with recommended dose modifications [see Dosage and Administration (2.2) ]. WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning.
Severe myelosuppression resulting in serious infection, septic shock, and death can occur ( 5.1 ). Decrease the dose or withhold vinorelbine in accord with recommended dose modifications ( 2.2 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Vinorelbine injection is indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) As a single agent for the treatment of patients with metastatic NSCLC Vinorelbine injection is a vinca alkaloid indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) ( 1 ) As a single agent for first-line treatment of patients with metastatic NSCLC ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION In combination with cisplatin: 25 to 30 mg/m 2 as an intravenous injection or infusion once weekly ( 2.1 ) Single agent: 30 mg/m 2 as intravenously once a week ( 2.1 ) Adjust dose in patients with decreased neutrophil counts or elevated serum total bilirubin ( 2.2 )
2.1Recommended Dosage In Combination with Cisplatin 100 mg/m 2 The recommended dosage of vinorelbine is 25 mg/m 2 administered as an intravenous injection or infusion over 6 to 10 minutes on Days 1, 8, 15 and 22 of a 28-day cycle in combination with cisplatin 100 mg/m 2 on Day 1 only of each 28-day cycle. In Combination with Cisplatin 120 mg/m 2 The recommended dosage of vinorelbine is 30 mg/m 2 administered as an intravenous injection or infusion over 6 to 10 minutes once a week in combination with cisplatin 120 mg/m 2 on Days 1 and 29, then every 6 weeks.
Single Agent The recommended dosage of vinorelbine is 30 mg/m 2 administered intravenously over 6 to 10 minutes once a week.
2.2Dosage Modifications Myelosuppression Hold or decrease the dose of vinorelbine in patients with decreased neutrophil counts according to the following schema [see Warnings and Precautions ( 5.1 )]: Neutrophils on Day of Treatment (cells/mm 3 ) Percentage of Starting Dose of Vinorelbine ≥ 1,500 100% 1,000 to 1,499 50% < 1,000 Do not administer vinorelbine. Repeat neutrophil count in one week. If three consecutive weekly doses are held because neutrophil count is < 1,000 cells/mm 3 , discontinue vinorelbine Note: For patients who experience fever and/or sepsis while neutrophil count is < 1,500 cells/mm 3 or had 2 consecutive weekly doses held due to neutropenia, subsequent doses of vinorelbine should be: > 1,500 75% 1,000 to 1,499 37.5% < 1,000 Do not administer vinorelbine.
Repeat neutrophil count in one week. Hepatic Impairment/Toxicity Reduce vinorelbine dose in patients with elevated serum total bilirubin concentration according to the following schema [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.6 )]: Serum Total Bilirubin Concentration (mg/dl) Percentage of Starting Dose of Vinorelbine ≤ 2.0 100% 2.1 to 3.0 50% > 3.0 25% Concurrent Myelosuppression and Hepatic Impairment/Toxicity In patients with both myelosuppression and hepatic impairment/toxicity, administer the lower of the doses based on the corresponding starting dose of vinorelbine determined from the above schemas.
Neurologic Toxicity Discontinue vinorelbine for Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher peripheral neuropathy or autonomic neuropathy causing constipation [see Warnings and Precautions ( 5.5 )].
2.3Preparation and Administration Preparation Dilute vinorelbine injection in an intravenous bag to a concentration between 0.5 mg/mL and 2 mg/mL. Use one of the following recommended solutions for dilution: 5% Dextrose Injection, USP 0.9% Sodium Chloride Injection, USP 0.45% Sodium Chloride Injection, USP 5% Dextrose and 0.45% Sodium Chloride Injection, USP Ringer's Injection, USP Lactated Ringer's Injection, USP Stability and Storage Conditions of Diluted Solutions Diluted vinorelbine injection may be used for up to 24 hours under normal room light when stored in polyvinyl chloride bags at 5° to 30°C (41° to 86°F).
Administration Administer diluted vinorelbine injection over 6 to 10 minutes into the side port of a free-flowing intravenous line followed by flushing with at least 75 to 125 mL of one of the solutions. Vinorelbine Injection must only be administered intravenously. It is extremely important that the intravenous needle or catheter be properly positioned before any vinorelbine is injected.
Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. If particulate matter is seen, vinorelbine injection should not be administered. Management of Suspected Extravasation If vinorelbine leakage into surrounding tissue occurs or i…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 1 mL (10 mg/mL) and 5 mL (50 mg/ 5 mL) clear colorless to pale yellow solution in single-dose vial Injection: 10 mg/mL and 50 mg/5 mL in single-dose vial ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None None
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hepatic Toxicity: Monitor hepatic function prior to initiation and during treatment ( 5.2 ) Severe constipation and bowel obstruction, including necrosis and perforation, occur. Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction and/or paralytic ileus. ( 5.3 ) Extravasation can result in severe tissue injury, local tissue necrosis and/or thrombophlebitis.
Immediately stop vinorelbine and institute recommended management procedures ( 5.4 ) Neurologic Toxicity: Severe sensory and motor neuropathies occur. Monitor patients for new or worsening signs and symptoms of neuropathy. Discontinue for Grade 2 or greater neuropathy ( 5.5 ) Pulmonary toxicity and respiratory failure occur.
Interrupt vinorelbine in patients who develop unexplained dyspnea or have any evidence of pulmonary toxicity. Permanently discontinue for confirmed interstitial pneumonitis or ARDA ( 5.6 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception ( 5.7 , 8.1 , 8.3 )
5.1Myelosuppression Myelosuppression, manifested by neutropenia, anemia and thrombocytopenia, occur in patients receiving vinorelbine as a single agent and in combination with cisplatin [see Adverse Reactions ( 6.1 , 6.2 )] . Neutropenia is the major dose-limiting toxicity with vinorelbine. Grade 3 to 4 neutropenia occurred in 53% of patients treated with vinorelbine at 30 mg/m 2 per week.
Dose adjustment due to myelosuppression occurred in 51% of patients (Study 2). In clinical trials with vinorelbine administered at 30 mg/m 2 per week, neutropenia resulted in hospitalizations for pyrexia and/or sepsis in 8% of patients. Death due to sepsis occurred in 1% of patients.
Neutropenia nadirs occur between 7 and 10 days after dosing with neutropenia count recovery usually occurring within the following 7 to 14 days. Monitor complete blood counts prior to each dose of vinorelbine. Do not administer vinorelbine to patients with neutrophil counts < 1,000 cells/mm 3 .
Adjustments in the dosage of vinorelbine should be based on neutrophil counts obtained on the day of treatment [see Dosage and Administration ( 2.2 )] .
5.2Hepatic Toxicity Drug-induced liver injury manifest by elevated aspartate aminotransferase (AST) and bilirubin occur in patients receiving vinorelbine as a single agent and in combination with cytotoxic agents. Assess hepatic function prior to initiation of vinorelbine and periodically during treatment. Reduce the dose of vinorelbine for patients who develop elevations in total bilirubin ≥2 times upper limit of normal [see Dosage and Administration ( 2.2 ) and Use in Specific Populations ( 8.6 )] .
5.3Severe Constipation and Bowel Obstruction Severe and fatal paralytic ileus, constipation, intestinal obstruction, necrosis, and perforation occur in patients receiving vinorelbine. Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction and/or paralytic ileus, considering adequate dietary fiber intake, hydration and routine use of stool softeners.
5.4Extravasation and Tissue Injury Extravasation of vinorelbine can result in severe irritation, local tissue necrosis and/or thrombophlebitis. If signs or symptoms of extravasation occur, immediately stop administration of vinorelbine and institute recommended management procedures [see Dosage and Administration (2.2) and Adverse Reaction (6.1) ].
5.5Neurologic Toxicity Sensory and motor neuropathies, including severe neuropathies, occur in patients receiving vinorelbine. Monitor patients for new or worsening signs and symptoms of neuropathy, such as paresthesia, hyperesthesia, hyporeflexia and muscle weakness while receiving vinorelbine. Discontinue vinorelbine for CTCAE Grade 2 or greater neuropathy [see Dosage and Administration (2.2) and Adverse Reaction (6.1) ].
5.6 Pulmonary Toxicity and Respiratory Failure Pulmonary toxicity, including…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ( 5.1 )] Hepatic Toxicity [see Warnings and Precautions ( 5.2 )] Severe Constipation and Bowel Obstruction [see Warnings and Precautions ( 5.3 )] Extravasation and Tissue Injury [see Warnings and Precautions ( 5.4 )] Neurologic Toxicity [see Warnings and Precautions ( 5.5 )] Pulmonary Toxicity and Respiratory Failure [see Warnings and Precautions ( 5.6 )] Most common adverse reactions (incidence ≥20%) are leukopenia, neutropenia, anemia, increased aspartate aminotransferase, nausea, vomiting, constipation, asthenia, injection site reaction and peripheral neuropathy ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under varying designs and in different patient populations, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial and may not reflect the rates actually observed in clinical practice. Single Agent The data below reflect exposure to vinorelbine as a single agent administered at a dose of 30 mg/m 2 on a weekly basis to 365 patients enrolled in 3 controlled studies for metastatic NSCLC and advanced breast cancer.
The population included 143 patients with previously untreated metastatic NSCLC (Study 3) who received a median of 8 doses of vinorelbine. The patients were aged 32 to 79 (median 61 years), 71% were male, 91% White, 48% had adenocarcinoma histology. The data also reflect exposure to vinorelbine in 222 patients with previously treated advanced breast cancer who received a median of 10 doses of vinorelbine.
Vinorelbine is not indicated for the treatment of breast cancer. Selected adverse reactions reported in these studies are provided in Tables 1 and 2. The most common adverse reactions (≥ 20%) of single agent vinorelbine were leukopenia, neutropenia, anemia, increased aspartate aminotransferase (AST), nausea, vomiting, constipation, asthenia, injection site reaction and peripheral neuropathy.
The most common (≥ 5%) Grade 3 or 4 adverse reactions were neutropenia, leukopenia, anemia, increased total bilirubin, increased AST, injection site reaction and asthenia. Approximately 49% of patients with NSCLC who were treated with vinorelbine experienced at least one dose reduction due to an adverse reaction. Thirteen percent of patients discontinued vinorelbine due to adverse reactions.
The most frequent adverse reactions leading to vinorelbine discontinuation were asthenia, dyspnea, nausea, constipation, anorexia, myasthenia and fever. Table 1. Hematologic Adverse Reactions Experienced in > 5% of Patients Receiving Vinorelbine All Patients NSCLC (N=365) (%) (N= 143) (%) * Grade based on modified criteria from the National Cancer Institute version 1. † Patients with NSCLC had not received prior chemotherapy.
The majority of the remaining patients had received prior chemotherapy. Laboratory Hematologic Neutropenia < 2,000 cells/mm 3 90 80 < 500 cells/mm 3 36 29 Leukopenia < 4,000 cells/mm 3 92 81 < 1,000 cells/mm 3 15 12 Thrombocytopenia < 100,000 cells/mm 3 5 4 Anemia < 11 g/dl 83 77 < 8 g/dl 9 1 Hospitalizations due to neutropenic complications 9 8 Table 2. Non-hematologic Adverse Reactions Experienced in ≥ 5% of Patients Receiving Vinorelbine All Grades Grades 3 to 4 All Patients(%) NSCLC(%) All Patients(%) NSCLC(%) * Grade based on modified criteria from the National Cancer Institute version 1. † Patients with NSCLC had not received prior chemotherapy.
The majority of the remaining patients had received prior chemotherapy ‡ Incidence of paresthesia plus hypesthesia. Laboratory Hepatic AST increased (N=346) 67 54 6 3 Bilirubin increased 13 9 7 5 (N=351) Clinical Nausea 44 34 2 1 Asthenia 36 27 7 5 Constipation 35 29 3 2 Injection si…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Inhibitors of CYP3A4: May cause earlier onset and/or increased severity of adverse reactions ( 7.1 )
7.1CYP3A Inhibitors Exercise caution in patients concurrently taking drugs known to inhibit CYP3A. Concurrent administration of vinorelbine with a CYP3A inhibitor may cause an earlier onset and/or an increased severity of adverse reactions.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed ( 8.2 )
8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )], Vinorelbine can cause fetal harm when administered to a pregnant woman. Available human data are insufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of vinorelbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively (see Data).
Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. Data Animal Data In a mouse embryo-fetal development study, administration of a single dose of vinorelbine at a dose level of 9 mg/m 2 or greater (approximately 0.33 times the recommended human dose based on body surface area) was embryotoxic and fetotoxic.
Vinorelbine was embryotoxic and fetotoxic to pregnant rabbits when administered every 6 days during the period of organogenesis at doses of 5.5 mg/m 2 (approximately 0.18 times the recommended human dose based on body surface area) or greater. At doses that did not cause maternal toxicity in either species, vinorelbine administration resulted in reduced fetal weight and delayed ossification.
8.2Lactation Risk Summary There are no data on the presence of vinorelbine in human milk or its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in breastfed infants from vinorelbine, advise women not to breastfeed during treatment with vinorelbine and for 9 days after the final dose.
8.3Females and Males of Reproductive Potential Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating vinorelbine [see Use in Specific Populations ( 8.1 )]. Contraception Females Vinorelbine can cause fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1 )] . Advise female patients of reproductive potential to use effective contraception during treatment with vinorelbine and for 6 months after the final dose.
Males Vinorelbine may damage spermatozoa [see Nonclinical Toxicology ( 13.1 )]. Advise males with female sexual partners of reproductive potential to use effective contraception during treatment with vinorelbine and for 3 months after the final dose. Infertility Males Based on animal findings, vinorelbine may impair fertility in males [see Nonclinical Toxicology ( 13.1 )].
8.4Pediatric Use The safety and effectiveness of vinorelbine in pediatric patients have not been established. Results from a single-arm study of vinorelbine administered at the dose of 33.75 mg/m 2 (for 35 patients) or at the dose of 30 mg/m 2 (for 11 patients) every week for 6 weeks followed by 2 weeks of rest were evaluated (courses of 8 weeks). Forty-six patients age 1 to 25 (median 11 years) with recurrent solid malignant tumors, including rhabdomyosarcoma or undifferentiated sarcoma (N=21 patients), neuroblastoma (N= 4 patients) and central nervous system (CNS) tumors (N=21 patients), were enrolled.
The most significant grade 3 or 4 hematological adverse reactions were neutropenia (70%) and anemia (33%). The most significant grade 3 or 4 non-hematological adverse reactions were motor (15%) or cranial (13%) neuropathy, hypoxia (13%) and dyspnea (11%). Objective tumor response was observed in 2 out of 21 patients with rhabdomyosarcoma or undifferentiated sarcoma.
No objective tumor response was observed in patients with CNS tumors (N=21) or neuroblastoma (N=4).
8.5Geriatric Use Of the 769 number of patients who received vinorelbine as a single agent and in combination with cisplatin in studies 1, 2 and 3, 247 patients were 6…
🆘 Overdosage ▾
10 OVERDOSAGE There is no known antidote for overdoses of vinorelbine. Overdoses involving quantities up to 10 times the recommended dose (30 mg/m 2 ) have been reported. The adverse reactions described were consistent with those listed in the ADVERSE REACTIONS section, including paralytic ileus, stomatitis and esophagitis.
Bone marrow aplasia, sepsis and paresis have also been reported. Fatalities have occurred following overdose of vinorelbine. If overdosage occurs, general supportive measures together with appropriate blood transfusions, growth factors and antibiotics should be instituted as deemed necessary by the physician.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Vinorelbine is a vinca alkaloid that interferes with microtubule assembly. The antitumor activity of vinorelbine is thought to be due primarily to inhibition of mitosis at metaphase through its interaction with tubulin. Vinorelbine may also interfere with: 1) amino acid, cyclic AMP and glutathione metabolism, 2) calmodulin-dependent Ca++-transport ATPase activity, 3) cellular respiration, and 4) nucleic acid and lipid biosynthesis.
Vinorelbine inhibited mitotic microtubule formation in intact mouse embryo tectal plates at a concentration of 2 µM inducing a blockade of cells at metaphase, but produced depolymerization of axonal microtubules at a concentration 40 µM, suggesting a modest selectivity of vinorelbine for mitotic microtubules.
12.3Pharmacokinetics The pharmacokinetics of vinorelbine were studied in 49 patients who received doses of 30 mg/m 2 administered as 15- to 20-minute constant-rate infusions. Vinorelbine concentrations in plasma decay in a triphasic manner. Distribution Steady-state volume of distribution (V SS ) values range from 25.4 to
40.1L/kg. Vinorelbine demonstrated high binding to human platelets and lymphocytes. The free fraction was approximately 0.11 in human plasma over a concentration range of 234 to 1169 ng/mL.
The binding to plasma constituents in cancer patients ranged from 79.6% to 91.2%. Vinorelbine binding was not altered in the presence of cisplatin, fluorouracil, or doxorubicin. Elimination The terminal phase half-life averages 27.7 to 43.6 hours and the mean plasma clearance ranges from 0.97 to
1.26L/hr/kg. Metabolism Vinorelbine undergoes substantial hepatic elimination in humans, with large amounts recovered in feces. Two metabolites of vinorelbine have been identified in human blood, plasma and urine; vinorelbine N-oxide and deacetylvinorelbine.
Deacetylvinorelbine has been demonstrated to be the primary metabolite of vinorelbine in humans and has been shown to possess antitumor activity similar to vinorelbine. Therapeutic doses of vinorelbine (30 mg/m 2 ) yield very small, if any, quantifiable levels of either metabolite in blood or urine. The metabolism of vinorelbine is mediated by hepatic CYP3A.
Excretion After intravenous administration of radioactive vinorelbine, approximately 18% and 46% of administered radioactivity was recovered in urine and feces, respectively. In a different study, 10.9% ± 0.7% of a 30 mg/m 2 intravenous dose was excreted as parent drug in urine. Specific Populations Age has no effect on the pharmacokinetics (CL, V SS and t 1/2 ) of vinorelbine.
Drug Interaction Studies The pharmacokinetics of vinorelbine are not influenced by the concurrent administration of cisplatin.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Vinorelbine Injection, USP is a clear, colorless to pale yellow solution in water for injection, USP containing 10 mg vinorelbine per mL. Vinorelbine Injection, USP is available in single-dose, clear glass vials with elastomeric stoppers and white (10 mg/mL) and lime green (50 mg/5 mL) caps, individually packaged in a carton in the following vial sizes: NDC Vinorelbine Injection, USP Package Factor 45963-607-55 10 mg/mL Single-Dose Vial 1 vial per carton 45963-607-56 50 mg/5 mL (10 mg/mL) Single-Dose Vial 1 vial per carton Storage Conditions Store the vials under refrigeration at 2° to 8°C (36° to 46°F) in the carton.
Unopened vials of Vinorelbine Injection, USP are stable at 25°C (77°F) for up to 72 hours. Protect from light. DO NOT FREEZE.
The vial stopper is not made with natural rubber latex. Sterile, Nonpyrogenic, Preservative-free. Vinorelbine Injection, USP is a cytotoxic drug.
Follow applicable special handling and disposal procedures. 1
📋 Description ▾
11 DESCRIPTION Vinorelbine tartrate, USP is a semi-synthetic vinca alkaloid for intravenous injection. Chemically, vinorelbine tartrate, USP is 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R-(R*,R*)-2, 3-dihydroxybutanedioate (1:2)(tartrate)] and has the following structure: C 45 H 54 N 4 O 8• 2C 4 H 6 O 6 M.W. 1079.12.
Vinorelbine Injection, USP is a sterile nonpyrogenic aqueous solution. Each milliliter of solution contains vinorelbine tartrate, USP equivalent to 10 mg vinorelbine in Water for Injection USP. The pH of Vinorelbine Injection, USP is approximately 3.5.
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💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Myelosuppression Advise patients to contact a healthcare provider for new onset fever, or symptoms of infection [see Warnings and Precautions (5.1) ]. Constipation and Bowel Obstruction Advise patients to follow a diet rich in fibers, drink fluids to stay well hydrated and use stool softeners to avoid constipation. Contact a health care provider for severe constipation, new onset abdominal pain, nausea and vomiting [see Warnings and Precautions (5.3) ].
Neurologic Toxicity Advise patients to contact a health care provider for new onset or worsening of numbness, tingling, decrease sensation or muscle weakness [see Warnings and Precautions (5.5) ]. Pulmonary Toxicity Advise patients to contact a healthcare provider for new onset or worsening of shortness of breath, cough, wheezing or other new pulmonary symptoms [see Warnings and Precautions (5.6) ]. Embryo-Fetal Toxicity Advise pregnant women of the potential risk to a fetus.
Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.1 , 8.3 )]. Advise females of reproductive potential to use effective contraception during treatment with vinorelbine and for 6 months after the final dose [see Use in Specific Populations ( 8.3 )]. Advise males with female partners of reproductive potential to use effective contraception during treatment with vinorelbine and for 3 months after the final dose [see Use in Specific Population ( 8.3 ) and Nonclinical Toxicology ( 13.1 )].
Lactation Advise women not to breastfeed during treatment with vinorelbine and for 9 days after the final dose [see Use in Specific Populations ( 8.2 )]. Infertility Advise males of reproductive potential that vinorelbine may impair fertility [see Use in Specific Populations ( 8.3 )]. Manufactured In Romania By: Sindan Pharma SRL Bucharest 1, Romania Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev.
D 5/2022