Navelbine

Last updated on RxList: 11/25/2020
Navelbine Side Effects Center

What Is Navelbine?

Navelbine (vinorelbine tartrate) is a cancer medication used to treat non-small cell lung cancer, and is sometimes used in combination with other cancer medications. Navelbine is available in generic form.

What Are Side Effects of Navelbine?

Common side effects of Navelbine include:

Temporary hair loss may occur. Normal hair growth should return after treatment with Navelbine has ended. Tell your doctor if you have serious side effects of Navelbine including:

  • numbness/tingling/pain in the hands or feet,
  • decreased reflexes,
  • mouth sores,
  • easy bruising or bleeding,
  • weakness,
  • new or increased trouble breathing,
  • cough,
  • severe constipation,
  • stomach or abdominal pain,
  • blood in the urine, or
  • mental/mood changes.

Dosage for Navelbine

The usual initial dose of Navelbine when used alone is 30 mg/m2 administered weekly by intravenous injection over 6 to 10 minutes.

What Drugs, Substances, or Supplements Interact with Navelbine?

When used in combination with cisplatin the dose of Navelbine is 100 mg/m2 given every 4 weeks. Navelbine may interact with conivaptan, diclofenac, imatinib, isoniazid, antibiotics, antifungals, antidepressants, heart or blood pressure medications, cancer medicines, or HIV/AIDS medicines. Tell your doctor all medications you use.

Navelbine During Pregnancy and Breastfeeding

Navelbine is not recommended for use during pregnancy. It may cause harm to a fetus. Women of childbearing age should use birth control during treatment and for some time afterwards. It is unknown if this drug passes into breast milk. Because of the potential risk to the infant, breastfeeding while using this drug is not recommended.

Additional Information

Our Navelbine (vinorelbine tartrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Lung Cancer: Early Signs, Symptoms, Stages See Slideshow
Navelbine Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe constipation, stomach pain, bloody or black stools;
  • numbness, tingling, muscle weakness;
  • pain, redness, and peeling skin on your hands or feet;
  • new or worsening cough, wheezing, chest tightness, trouble breathing;
  • dark urine, jaundice (yellowing of the skin or eyes);
  • pain, burning, irritation, or skin changes where the injection was given; or
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Talk with your doctor about ways to avoid severe constipation while you are being treated with vinorelbine.

Common side effects may include:

  • nausea, vomiting, constipation;
  • weakness;
  • numbness or tingling in your hands or feet;
  • low blood cell counts;
  • abnormal liver function tests; or
  • pain, redness, bruising, or irritation around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Navelbine (Vinorelbine Tartrate)

QUESTION

Lung cancer is a disease in which lung cells grow abnormally in an uncontrolled way. See Answer
Navelbine Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Myelosuppression [see WARNINGS AND PRECAUTIONS]
  • Hepatic Toxicity [see WARNINGS AND PRECAUTIONS]
  • Severe Constipation and Bowel Obstruction [see WARNINGS AND PRECAUTIONS]
  • Extravasation and Tissue Injury [see WARNINGS AND PRECAUTIONS]
  • Neurologic Toxicity [see WARNINGS AND PRECAUTIONS]
  • Pulmonary Toxicity and Respiratory Failure [see WARNINGS AND PRECAUTIONS]

Clinical 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 NAVELBINE 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 patients with previously untreated metastatic NSCLC (Study 3) who received a median of 8 doses of NAVELBINE. 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 NAVELBINE in 222 patients with previously treated advanced breast cancer who received a median of 10 doses of NAVELBINE. NAVELBINE 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 NAVELBINE 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 NAVELBINE experienced at least one dose reduction due to an adverse reaction.

Thirteen percent of patients discontinued NAVELBINE due to adverse reactions. The most frequent adverse reactions leading to NAVELBINE discontinuation were asthenia, dyspnea, nausea, constipation, anorexia, myasthenia and fever.

Table 1: Hematologic Adverse Reactions Experienced in > 5% of Patients Receiving NAVELBINE*†:

All Patients
(N=365) (%)
NSCLC
(N=143) (%)
Laboratory
Hematologic
Neutropenia< 2,000 cells/mm³9080
< 500 cells/mm³3629
Leukopenia< 4,000 cells/mm³9281
< 1,000 cells/mm³1512
Thrombocytopenia< 100,000 cells/mm³54
Anemia< 11 g/dl8377
< 8 g/dl91
Hospitalizations due to neutropenic complications98
*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.

Table 2: Non-hematologic Adverse Reactions Experienced in ≥ 5% of Patients Receiving NAVELBINE*†:

All GradesGrade 3-4
All Patients (%)NSCLC (%)All Patients (%)NSCLC (%)
Laboratory
Hepatic
AST increased (N=346)675463
Bilirubin increased (N=351)13975
Clinical
Nausea443421
Asthenia362775
Constipation352932
Injection site reaction283825
Injection site pain161321
Neuropathy peripheral‡2520<21
Vomiting201521
Diarrhea171311
Alopecia1212<11
Phlebitis710<11
Dyspnea7332
* 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.

Myelosuppression

In clinical trials, Grade 3-4 neutropenia, anemia and thrombocytopenia occurred in 69%, 9% and 1%, respectively of patients receiving single agent NAVELBINE. 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 NAVELBINE.

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 <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 <1% of patients.

In Combination With Cisplatin

Table 3 presents the incidence of selected adverse reactions, occurring in ≥10% of NAVELBINE treated patients reported in a randomized trial comparing the combination of NAVELBINE 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 NAVELBINE plus cisplatin received a median of 3 cycles of treatment and those randomized to cisplatin alone received a median of 2 cycles of treatment. The incidence of Grade 3 and 4 neutropenia was significantly higher in the NAVELBINE plus cisplatin arm (82%) compared to the cisplatin alone arm (5%).

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.

Four patients in the NAVELBINE 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 NAVELBINE and 3 from febrile neutropenia.

Table 3: Adverse Reactions Experienced by ≥ 10% of Patients on NAVELBINE plus Cisplatin versus Single-Agent Cisplatin*

NAVELBINE 25mg/m² plus Cisplatin 100 mg/m²
(N=212)
Cisplatin 100mg/m²
(N=210)
All Grades (%)Grades 3-4 (%)All Grades (%)Grades 3-4 (%)
Laboratory
Hematologic
Neutropenia8982265
Anemia892472<8
Leukopenia885831<1
Thrombocytopenia29521<2
Febrile neutropenia†N/A11N/A0
Renal
Blood creatinine increased37428<5
Clinical
Malaise/Fatigue/Lethargy6712498
Vomiting60136014
Nausea58145712
Decreased apetite460370
Constipation353161
Alopecia340140
Weight decreased34121<1
Fever without infection20240
Hearing impaired18418<4
Injection site reaction17<110
Diarrhea17<311<2
Paraesthesia17<110<1
Taste alterations170150
Peripheral numbness1127<1
Myalgia/Arthralgia12<13<1
Phlebitis/Thrombosis/Embolism103<1<1
Weakness12<372
Infection11<6<1<1
Respiratory tract infection10<533
* Graded according to the standard SWOG criteria version 1.
† Categorical toxicity grade not specified

Table 4 presents the incidence of selected adverse reactions, occurring in ≥10% of NAVELBINE treated patients reported in a randomized trial of NAVELBINE plus cisplatin, vindesine plus cisplatin and NAVELBINE as a single agent in patients with stage III or IV NSCLC who had not received prior chemotherapy. A total of 604 patients received either NAVELBINE 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 NAVELBINE 30mg/m² every week (N=204).

Patients randomized to NAVELBINE plus cisplatin received a median of 15 weeks of treatment, vindesine plus cisplatin 12 weeks and NAVELBINE received 13 weeks. Grade 3 and 4 neutropenia was significantly greater in the NAVELBINE plus cisplatin arm (78%) compared to vindesine plus cisplatin (48%) and NAVELBINE as a single agent (53%). Neurotoxicity, including peripheral neuropathy and constipation, was reported in 44% (Grade 3-4, 7%) of the patients receiving NAVELBINE plus cisplatin, 58% (Grade 3-4, 17%) of the patients receiving vindesine and cisplatin and 44% (Grade 3-4, 8.5%) of the patients receiving NAVELBINE as a single agent.

Study discontinuation due to an adverse reaction was required in 27, 22 and 10% of the patients randomized to NAVELBINE plus cisplatin, vindesine plus cisplatin and cisplatin alone arms, respectively.

Table 4: Adverse Reactions Experienced by ≥ 10 % of Patients from a Comparative Trial of NAVELBINE Plus Cisplatin versus Vindesine Plus Cisplatin versus Single Agent NAVELBINE*

NAVELBINE/ Cisplatin†Vindesine/ Cisplatin‡NAVELBINE§
All Grades (%)Grades 3-4 (%)All Grades (%)Grades 3-4 (%)All Grades (%)Grades 3-4 (%)
Laboratory
Hematologic
Neutropenia957879488553
Leukopenia945782278332
Thrombocytopenia154103.530
Renal
Blood creatinine increased|46N/A37N/A13N/A
Clinical
Nausea/Vomiting74307225312
Alopecia517.55614302
Neurotoxicity¶4475817448.5
Diarrhea251.5241120.5
Injection site reaction172.570222
Ototoxicity10214110
* Grade based on criteria from the World Health Organization (WHO).
† N=194 to 207; all patients receiving NAVELBINE/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 NAVELBINE with laboratory and non-laboratory data.
¦Categorical toxicity grade not specified.
¶ Neurotoxicity includes peripheral neuropathy and constipation.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of NAVELBINE. 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: 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), palmar-plantar erythrodysesthesia syndrome

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

Read the entire FDA prescribing information for Navelbine (Vinorelbine Tartrate)

© Navelbine Patient Information is supplied by Cerner Multum, Inc. and Navelbine Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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