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Vilbine

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Vilbine uses


WARNING: MYELOSUPPRESSION


WARNING: MYELOSUPPRESSION

See full prescribing information for complete boxed warning.

1 INDICATIONS AND USAGE

Vilbine injection, USP is indicated:


Vilbine injection, USP is a vinca alkaloid indicated:

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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

In Combination with Cisplatin 100 mg/m 2


In Combination with Cisplatin 120 mg/m 2

2.2 Dose Modifications

Hematologic Toxicity

Hold or decrease the dose of Vilbine in patients with decreased neutrophil counts using the following schema.

Neutrophils on Day of Treatment (Cells/mm 3 ) Percentage of Starting Dose of Vilbine
≥ 1,500 100%
1,000 to 1,499 50%
< 1,000 Do not administer Vilbine. Repeat neutrophil count in one week. If three consecutive weekly doses are held because Neutrophil count is < 1,000 cells/mm3, discontinue Vilbine
Note : For patients who experience fever and/or sepsis while neutrophil count is < 1,500 or had 2 consecutive weekly doses held due to neutropenia, subsequent doses of Vilbine should be:
> 1,500 75%
1,000 to 1,499 37.5%
< 1,000 Do not administer Vilbine.
Repeat neutrophil count in one week.

Hepatic Impairment/Toxicity

Reduce Vilbine dose in patients with elevated serum total bilirubin concentration according to the following schema:

Serum total bilirubin concentration (mg/dl) Percentage of Starting Dose of Vilbine
≤ 2.0 100%
2.1 to 3.0 50%
> 3.0 25%

Concurrent Hematologic Toxicity and Hepatic Impairment

In patients with both hematologic toxicity and hepatic impairment, administer the lower of the doses based on the corresponding starting dose of Vilbine determined from the above schemas.

Neurologic Toxicity

Discontinue Vilbine for NCI CTCAE Grade 2 or higher peripheral neuropathy or autonomic neuropathy causing constipation.

2.3 Preparation and Administration

Preparation of Vilbine Injection, USP

Dilute Vilbine Injection, USP in either a syringe or intravenous bag using one of the recommended solutions.

Syringe

Dilute to a concentration between 1.5 and 3 mg/mL. The following solutions may be used for dilution:


Intravenous Bag

Dilute to a concentration between 0.5 and 2 mg/mL. The following solutions may be used for dilution:


Stability

Diluted Vilbine Injection, USP may be used for up to 24 hours under normal room light when stored in polypropylene syringes or polyvinyl chloride bags at 5° to 30°C (41° to 86°F).

Administration

Administer diluted Vilbine Injection, USP 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.

Vilbine Injection, USP must only be administered intravenously. It is extremely important that the intravenous needle or catheter be properly positioned before any Vilbine 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, Vilbine Injection, USP should not be administered.

Management of Suspected Extravasation

2.4 Procedures for Proper Handling and Disposal

Handle and dispose Vilbine Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs1.

Exercise caution in handling and preparing the solution of Vilbine Injection, USP. The use of gloves is recommended. If the solution of Vilbine Injection, USP contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water.

Avoid contamination of the eye with Vilbine Injection, USP. If exposure occurs, flush the eyes with water immediately and thoroughly.

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3 DOSAGE FORMS AND STRENGTHS

Vilbine Injection, USP

Clear colorless to pale yellow solution in single use vials:

1 mL (10 mg/1 mL)

5 mL (50 mg/5 mL)

4 CONTRAINDICATIONS

None

None

5 WARNINGS AND PRECAUTIONS

5.1 Myelosuppression

Myelosuppression manifested by neutropenia, anemia and thrombocytopenia occur with Vilbine as a single agent and in combination with cisplatin. Neutropenia is the major dose-limiting toxicity with Vilbine. Grade 3-4 neutropenia occurred in 53% of patients treated with Vilbine at 30 mg/m2 per week. Dose adjustment due to myelosuppression occurred in 51% of patients (Study 2). In clinical trials with Vilbine administered at 30 mg/m2 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 Vilbine. Do not administer Vilbine to patients with neutrophil counts less than 1,000 cells/mm3. Adjustments in the dosage of Vilbine should be based on neutrophil counts obtained on the day of treatment.

5.2 Hepatic Toxicity

Drug-induced liver injury manifest by elevations of aspartate aminotransferase and bilirubin can occur in patients receiving Vilbine alone or in combination with cytotoxic agents. Assess hepatic function prior to initiation of Vilbine and periodically during treatment. Reduce the dose of Vilbine for patients who develop elevations in total bilirubin greater than 2 times upper limit of normal.

5.3 Severe Constipation and Bowel Obstruction

Severe and fatal paralytic ileus, constipation, intestinal obstruction, necrosis, and perforation occur with Vilbine administration. 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.

5.4 Extravasation and Tissue Injury

Extravasation of Vilbine can result in severe irritation, local tissue necrosis and/or thrombophlebitis. If signs or symptoms of extravasation occur, immediately stop administration of Vilbine and institute recommended management procedures.

5.5 Neurologic Toxicity

Sensory and motor neuropathies, including severe neuropathies, occur in patients receiving Vilbine. Monitor patients for new or worsening signs and symptoms of neuropathy such as paresthesia, hyperesthesia, hyporeflexia and muscle weakness while receiving Vilbine. Discontinue Vilbine for NCI CTCAE Grade 2 or greater neuropathy

5.6 Pulmonary Toxicity and Respiratory Failure

Pulmonary toxicity, including severe acute bronchospasm, interstitial pneumonitis, acute respiratory distress syndrome occurs with use of Vilbine. Interstitial pneumonitis and ARDS included fatalities. The mean time to onset of interstitial pneumonitis and ARDS after Vilbine administration was one week (range 3 to 8 days).

Interrupt Vilbine in patients who develop unexplained dyspnea, or have any evidence of pulmonary toxicity. Permanently discontinue Vilbine for confirmed interstitial pneumonitis or ARDS.

5.7 Embryo-Fetal Toxicity

Vilbine can cause fetal harm when administered to a pregnant woman. In animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of Vilbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during therapy with Vilbine.

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6 ADVERSE REACTIONS

The following serious adverse reactions, which may include fatalities, are discussed in greater detail in other sections of the label:


Most common adverse reactions (incidence greater than or equal to 20%) are neutropenia, anemia, liver enzyme elevation, nausea, vomiting, asthenia, constipation, injection site reaction, and peripheral neuropathy (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trial 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 Vilbine as a single agent administered at a dose of 30 mg/m2 on a weekly basis to 365 patients enrolled in 3 controlled studies for metastatic NSCLC and advanced breast cancer. The population included 143 previously untreated metastatic NSCLC patients (Study 3) who received a median of 8 doses of Vilbine. The patients were aged 32 to 79 (median 61 years), 71% were male, 91% Caucasian, 48% had adenocarcinoma histology. The data also reflect exposure to Vilbine in 222 patients with previously treated advanced breast cancer who received a median of 10 doses of Vilbine. Vilbine 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 (greater than or equal to 20%) of single agent Vilbine were leukopenia, neutropenia, anemia, Aspartate aminotransferase (AST) elevation, nausea, vomiting, constipation, asthenia, injection site reaction, and peripheral neuropathy. The most common (greater than or equal to 5%) Grade 3 or 4 adverse reactions were neutropenia, leukopenia, anemia, increased total bilirubin, AST elevation, injection site reaction and asthenia. Approximately 49% of NSCLC patients treated with Vilbine experienced at least one dose reduction due to an adverse reaction. Thirteen percent of patients discontinued Vilbine due to adverse reactions. The most frequent adverse reactions leading to Vilbine discontinuation were asthenia, dyspnea, nausea, constipation, anorexia, myasthenia and fever.

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/mm3 90% 80%
< 500 cells/mm3 36% 29%
Leukopenia < 4,000 cells/mm3 92% 81%
< 1,000 cells/mm3 15% 12%
Thrombocytopenia < 100,000 cells/mm3 5% 4%
Anaemia < 11 g/dl 83% 77%
< 8 g/dl 9% 1%
Hospitalizations due to neutropenic complications 9% 8%
All grades Grades 3+4
All Patients NSCLC All Patients NSCLC
* Grade based on modified criteria from the National Cancer Institute version 1.
‡ Incidence of paresthesia plus hypesthesia.
†Patients with NSCLC had not received prior chemotherapy. The majority of the remaining patients had received prior chemotherapy.
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 site reaction 28% 38% 2% 5%
Injection site pain 16% 13% 2% 1%
Neuropathy peripheral‡ 25% 20% <2% 1%
Vomiting 20% 15% 2% 1%
Diarrhea 17% 13% 1% 1%
Alopecia 12% 12% ≤1% 1%
Phlebitis 7% 10% <1% 1%
Dyspnea 7% 3% 3% 2%

Myelosuppression: In clinical trials, Grade 3-4 neutropenia, anemia, and thrombocytopenia occurred in 69%, 9% and 1%, respectively of patients receiving single-agent Vilbine. Neutropenia is the major dose-limiting toxicity.

Neurotoxicity: neurotoxicity was most commonly manifested as constipation, paresthesia, hypersthesia, and hyporeflexia. Grade 3 and 4 neuropathy was observed in 1% of the patients receiving single-agent Vilbine.

Injection site reactions: Injection site reactions, including erythema, pain at injection site, and vein discoloration, occurred in approximately one third of patients; 5% were severe. Phlebitis (chemical phlebitis) along the vein proximal to the site of injection was reported in 10% of patients.

Cardiovascular toxicity: Chest pain occurred in 5% of patients; myocardial infarction occurred in less than 0.1% of patients.

Pulmonary Toxicity and Respiratory Failure: Dyspnea (shortness of breath) was reported in 3% of patients; it was severe in 2%. Interstitial pulmonary changes were documented.

Other: Hemorrhagic cystitis and the syndrome of inappropriate ADH secretion were each reported in less than 1% of patients.

In Combination with Cisplatin

Table 3 presents the incidence of selected adverse reactions, occurring in greater than or equal to 10% of Vilbine treated patients reported in a randomized trial comparing the combination of Vilbine 25 mg/m2 administered every week of each 28-day cycle and cisplatin 100 mg/m2 administered on day 1 of each 28-day cycle versus cisplatin alone at the same dose and schedule in patients with previously untreated NSCLC (Study 1).

Patients randomized to Vilbine plus cisplatin received a median of 3 cycles of treatment and those randomized to cisplatin alone received a median of 2 cycles of treatment. Thirty-Five percent of the eligible patients in the combination arm required treatment discontinuation due to an adverse reaction compared to 19% in the cisplatin alone arm. The incidence of Grade 3 and 4 neutropenia was significantly higher in the Vilbine plus cisplatin arm (82%) compared to the cisplatin alone arm (5%). Four patients in the Vilbine plus cisplatin arm died of neutropenic sepsis. Seven additional deaths were reported in the combination arm: 2 from cardiac ischemia, 1 cerebrovascular accident, 1 multisystem failure due to an overdose of Vilbine, and 3 from febrile neutropenia.

Vilbine 25mg/m 2 plus Cisplatin 100mg/m 2 (n=210)
Cisplatin 100 mg/m 2 (n=212)
All Grades Grades 3+4 All Grades Grades 3+4
*Graded according to the standard SWOG criteria version 1.
*Categorical toxicity grade not specified
Laboratory
Hematologic
Neutropenia 89% 82% 26% 5%
Anemia 89% 24% 72% <8%
Leukopenia 88% 58% 31% <1%
Thrombocytopenia 29% 5% 21% <2%
Febrile neutropenia N/A* 11% N/A* 0%
Renal
Blood creatinine increased 37% 4% 28% <5%
Clinical
Malaise/Fatigue/Lethargy 67% 12% 49% 8%
Vomiting 60% 13% 60% 14%
Nausea 58% 14% 57% 12%
Decreased appetite 46% 0% 37% 0%
Constipation 35% 3% 16% 1%
Alopecia 34% 0% 14% 0%
Weight decreased 34% 1% 21% <1%
Fever without infection 20% 2% 4% 0%
Hearing impaired 18% 4% 18% <4%
Injection site reaction 17% <1% 1% 0%
Diarrhea 17% <3% 11% <2%
Paraesthesia 17% <1% 10% <1%
Taste alterations 17% 0% 15% 0%
Peripheral numbness 11% 2% 7% <1%
Myalgia/Arthralgia 12% <1% 3% <1%
Phlebitis/Thrombosis/Embolism 10% 3% <1% <1%
Weakness 12% <3% 7% 2%
Infection 11% <6% <1% <1%
Respiratory tract infection 10% <5% 3% 3%

Table 4 presents the incidence of selected adverse reactions, occurring in greater than or equal to 10% of Vilbine treated patients reported in a randomized trial of Vilbine plus cisplatin, vindesine plus cisplatin and Vilbine alone in patients with stage III or IV NSCLC who had not received prior chemotherapy. A total of 604 patients received either Vilbine 30 mg/m2 every week plus cisplatin 120 mg/m2 on Day 1 and Day 29, then every 6 weeks thereafter (N=207), vindesine 3 mg/m2 for 6 weeks, then every other week thereafter plus cisplatin 120 mg/m2 on Days 1 and Day 29, then every 6 weeks thereafter (N=193) or Vilbine 30mg/m2 every week (N=204).

Patients randomized to Vilbine plus cisplatin received a median of 15 weeks of treatment, vindesine plus cisplatin 12 weeks and Vilbine received 13 weeks. Study discontinuation due to an adverse reaction was required in 27, 22 and 10% of the patients randomized to Vilbine plus cisplatin, vindesine plus cisplatin and cisplatin alone arms, respectively. Grade 3 and 4 neutropenia was significantly greater in the Vilbine plus cisplatin arm (78%) compared to vindesine plus cisplatin (48%) and Vilbine alone (53%). Neurotoxicity, including peripheral neuropathy and constipation was reported in 44% (Grades 3-4, 7%) of the patients receiving Vilbine plus cisplatin, 58% (Grades 3-4, 17%) of the patients receiving vindesine and cisplatin and 44% (Grades 3-4, 8.5%) of the patients receiving Vilbine alone.

Vilbine /Cisplatin† Vindesine/Cisplatin‡ Vilbine §
All Grades Grades 3+4 All Grades Grades 3+4 All Grades Grades 3+4
* Grade based on criteria from the World Health Organization (WHO).
† n=194 to 207; all patients receiving vinorelbine/cisplatin with laboratory and non-laboratory data.
‡ n=173 to 192; all patients receiving vindesine/cisplatin with laboratory and non-laboratory data.
§ n=165 to 201; all patients receiving Vilbine with laboratory and non-laboratory data.
¦ Categorical toxicity grade not specified.
¶ Neurotoxicity includes peripheral neuropathy and constipation.
Laboratory
Hematologic
Neutropenia 95% 78% 79% 48% 85% 53%
Leukopenia 94% 57% 82% 27% 83% 32%
Thrombocytopenia 15% 4% 10% 3.5% 3% 0%
Renal
Blood creatinine 46% N/A 37% N/A 13% N/A
increased ¦
Clinical
Nausea/Vomiting 74% 30% 72% 25% 31% 2%
Alopecia 51% 7.5% 56% 14% 30% 2%
Neurotoxicity ¶ 44% 7% 58% 17% 44% 8.5%
Diarrhea 25% 1.5% 24% 1% 12% 0.5%
Injection site 17% 2.5% 7% 0% 22% 2%
reaction
Ototoxicity 10% 2% 14% 1% 1% 0%

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Vilbine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections and infestations: pneumonia

Immune system disorders: anaphylactic reaction, pruritus, urticaria, angioedema

Nervous system disorders: loss of deep tendon reflexes, muscular weakness, gait disturbance, headache

Ear and labyrinth disorders: vestibular disorder, hearing impaired

Cardiac disorders: tachycardia

Respiratory disorders: pulmonary edema

Vascular disorders: pulmonary embolism, deep vein thrombosis, hypertension, hypotension, flushing, vasodilatation

Gastrointestinal disorders: mucosal inflammation, dysphagia, pancreatitis

Skin disorders: generalized cutaneous reactions (rash)

Musculoskeletal and connective tissue disorders: jaw pain, myalgia, arthralgia

General disorders and administration site conditions: injection site rash, urticaria, blistering, sloughing of skin

Injury, poisoning and procedural complications: radiation recall phenomenon, dermatitis, esophagitis

Laboratory abnormalities: electrolyte imbalance including hyponatremia

Other: tumor pain, back pain, abdominal pain

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7 DRUG INTERACTIONS

7.1 CYP3A Inhibitors

Exercise caution in patients concurrently taking drugs known to inhibit drug metabolism by hepatic cytochrome P450 isoenzymes in the CYP3A subfamily. Concurrent administration of Vilbine with an inhibitor of this metabolic pathway may cause an earlier onset and/or an increased severity of adverse reactions.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category D

Risk Summary

Vilbine can cause fetal harm when administered to a pregnant woman. In animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of Vilbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus.

Animal Data

In a mouse embryofetal development study, administration of a single dose of Vilbine at a dose level of 9 mg/m2 or greater (approximately 0.33 times the recommended human dose based on body surface area) was embryotoxic and fetotoxic. Vilbine was embryotoxic and fetotoxic to pregnant rabbits when administered every 6 days during the period of organogenesis at doses of 5.5 mg/m2 (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, Vilbine administration resulted in reduced fetal weight and delayed ossification.

8.3 Nursing Mothers

It is not known whether this drug is present in human milk. Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from Vilbine, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

8.4 Pediatric Use

The safety and effectiveness of Vilbine in pediatric patients have not been established. Results from a single-arm study of Vilbine administered at the dose of 33.75 mg/m2 or at the dose of 30mg/m2 (for 11 patients) every week during 6 weeks followed by 2 weeks of rest was 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 toxicity 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).

8.5 Geriatric Use

Of the 769 number of patients who received Vilbine alone and Vilbine in combination with Cisplatin in studies 1, 2 and 3, 247 patients were 65 years of age or older. No overall differences in safety, efficacy and pharmacokinetic parameters were observed between these patients and younger patients..

8.6 Hepatic Impairment

The influence of hepatic impairment on the pharmacokinetics of Vilbine has not been evaluated, but the liver plays an important role in the metabolism of Vilbine. Elevations of aspartate aminotransferase occur in greater than 60% of the patients receiving Vilbine alone. Therefore, exercise caution in patients with hepatic impairment. Reduce the dose of Vilbine for patients with bilirubin elevation.

8.7 Females and Males of Reproductive Potential

Contraception

Females

Vilbine can cause fetal harm when administered to a pregnant woman. Advise female patients of reproductive potential to use highly effective contraception during therapy with Vilbine.

Males

Vilbine may damage spermatozoa. Males with female sexual partners of reproductive potential should use highly effective contraception during and for 3 months after therapy with Vilbine.

Fertility

Males

Based on animal findings, Vilbine may cause decreased fertility in males

10 OVERDOSAGE

There is no known antidote for overdoses of Vilbine. Overdoses involving quantities up to 10 times the recommended dose (30 mg/m2) have been reported. The toxicities 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 Vilbine. If overdosage occurs, general supportive measures together with appropriate blood transfusions, growth factors, and antibiotics should be instituted as deemed necessary by the physician.

11 DESCRIPTION

Vilbine tartrate, USP is a semi-synthetic vinca alkaloid for intravenous injection. Chemically, Vilbine tartrate, USP is 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R--2, 3-dihydroxybutanedioate (1:2)(tartrate)] and has the following structure:

Cisplatin 120 mg/m 2

Study 2 was a randomized, 3-arm, open-label, multicenter trial of Vilbine plus cisplatin, vindesine plus cisplatin and Vilbine alone for the treatment of patients with stage III or IV NSCLC who had not received prior chemotherapy. The study was conducted in Europe. A total of 612 patients were randomized 1:1:1 to receive Vilbine 30 mg/m2 every week of a 6-week cycle plus cisplatin 120 mg/m2 on Day 1 and Day 29, then every 6 weeks thereafter (N=206); and vindesine 3 mg/m2 for 6 weeks, then every other week thereafter plus cisplatin 120 mg/m2 on Days 1 and Day 29, then every 6 weeks thereafter (N=200) or Vilbine 30mg/m2 every week of a 6-week cycle (N=206). The main efficacy outcome measure was to compare overall survival between Vilbine plus cisplatin and vindesine plus cisplatin. The other efficacy outcome measure was to compare overall survival in the better of the two combination regimens to that of Vilbine alone.

Patient demographics were in general similar between arms: the median age of the overall population was 60 years (range 30 to 75), 90% were male, 78% had WHO performance status of 0 or 1. Tumor characteristics were in general similar with the exception of histologic subtype of NSCLC. Adenocarcinoma was the histologic subtype in 32% of patients in the Vilbine plus cisplatin arm, 40% of patients in vindesine plus cisplatin arm and 28% of patients on the Vilbine alone arm. Ten percent of the patients had stage IIIA disease, 28% stage IIIB and 50% stage IV. Twelve percent of the patients had received prior surgery or radiotherapy.

The efficacy results of Study 2 are presented in Table 8.

Vilbine Alone Vilbine plus Vindesine plus
(N=206) cisplatin (N=206) cisplatin (N=200)
1n/a = not applicable
Median survival in months (99.5% CI) 7.2 (5.4 to 9.1) 9.2 (7.4 to 11.1) 7.4 (6.1 to 9.1)
Unstratified log-rank n/a1 0.087
p-value 0.05 n/a
Overall Response
(ORR) N=205 N=203 N=198
Evaluable Patients 14% (10%, 20%) 28% (22%, 35%) 19% (14%, 25%)
ORR (95% CI)
Chi-square test n/a 0.03
p-value < 0.001 n/a
3c00b60d-figure-02

14.2 Single Agent

The safety and efficacy of Vilbine as a single agent was evaluated in one randomized multi-center trial.

Study 3 was a randomized, open-label clinical trial of Vilbine or 5-Fluorouracil (5-FU) plus leucovorin (LV) in patients with Stage IV NSCLC who had not received prior chemotherapy A total of 211 patients were randomized 2:1 to receive Vilbine 30 mg/m2 weekly of a 8-week cycle (N=143) or 5-FU 425 mg/m2 bolus intravenously plus LV 20 mg/m2 bolus intravenously daily for 5 days of a 4-weeks cycle (N=68).

Patient demographics and disease characteristics were in general similar between arms. In the overall population, the median age was 61 years (range 32 to 83), 74% were male, 88% were Caucasian, 46% had adenocarcinoma histology. Fifty percent of the patients had Karnofsky performance status greater than or equal to 90 in the Vilbine arm compared to 38% in the 5-FU and LV arm.

The primary efficacy outcome of the study was overall survival. The median survival time was 30 weeks versus 22 weeks for patients receiving Vilbine versus 5-FU/LV, respectively (P=0.06). Partial objective responses were observed in 11.1% (95% CI=6.2%, 17.9%) and 3.5% (95% CI=0.4%, 11.9%) of patients who received Vilbine and 5-FU/LV, respectively.

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

Vilbine Injection, USP is a clear, colorless to pale yellow solution in Water for Injection, containing 10 mg Vilbine per mL. Vilbine Injection, USP is available in single-use, clear glass vials with elastomeric stoppers and red (10 mg/1 mL) and 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/1 mL Single-Use Vial 1 vial per carton
45963-607-56 50 mg/5 mL Single-Use 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 Vilbine Injection, USP are stable at 25°C (77°F) for up to 72 hours.

Protect from light.

DO NOT FREEZE.

The container closure is not made with natural rubber latex.

Sterile, Nonpyrogenic, Preservative-free.

Vilbine Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

17 PATIENT COUNSELING INFORMATION

Inform patients of the following:


Made in Italy

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Revised – May 2015

Vilbine pharmaceutical active ingredients containing related brand and generic drugs:


Vilbine available forms, composition, doses:


Vilbine destination | category:


Vilbine Anatomical Therapeutic Chemical codes:


Vilbine pharmaceutical companies:


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References

  1. Dailymed."VINORELBINE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "vinorelbine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "vinorelbine". http://www.drugbank.ca/drugs/DB0036... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Vilbine?

Depending on the reaction of the Vilbine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Vilbine not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Vilbine addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Vilbine, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Vilbine consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology


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