Velban

Pregnancy Category: D

Lactation: not known if excreted in breast milk, do not nurse

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Mechanism of Action

Vinca alkaloid; acts in M & S phases by inhibiting microtubule formation, which disrupts the formation of the mitotic spindle in turn causing subsequent inhibition on DNA/RNA synthesis

Pharmacokinetics

Half-Life (triphasic): 4 min, 1.4 hr, & 24.8 hr

Peak Plasma: 150 ng/mL

Protein Bound: 99%

Vd: 27.3 L/kg

Metabolism: CYP3A4 activity

Metabolites: Desacetylvinblastine

Clearance: 0.74 L/kg/hr

Excretion: Bile (99%), urine (1%)

Velban is a prescription medication used to treat a variety of cancers including Hodgkin's disease, lymphoma, breast cancer, testicular cancer, and a certain type of uterine cancer. Velban belongs to a group of drugs called vinca alkaloids which work by slowing the growth and replication of cancer cells.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare provider.

Common side effects of Velban include hair loss, nausea, vomiting, constipation, and diarrhea.

Velban is part of the drug class:

• Vinca alkaloids and analogues

Vinblastine is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Vinblastine is used to treat Hodgkin's disease, certain types of lymphoma, testicular cancer, breast cancer, choriocarcinoma (a type of uterine cancer), Kaposi's sarcoma, and Letterer-Siwe disease.

Vinblastine is often used in combination with other cancer medications.

Vinblastine may also be used for purposes not listed in this medication guide.

You should not receive this medicine if you have severely low white blood cell counts, or an untreated or uncontrolled bacterial infection.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when vinblastine is injected.

Vinblastine is injected into a vein through an IV. A healthcare provider will give you this injection.

Vinblastine is usually given once every 7 days. Follow your doctor's instructions.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when vinblastine is injected.

Vinblastine can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

You may need frequent medical tests to be sure this medication is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.

Talk to your doctor about ways to avoid constipation while being treated with vinblastine.

Call your doctor for instructions if you miss an appointment for your vinblastine injection.

General

• Consult specialized references for procedures for proper handling and disposal of antineoplastics.127

• Care must be taken to avoid contact with the eyes as severe irritation and possibly corneal ulceration (especially if administered under pressure) can result; if contact occurs, immediately wash eyes thoroughly.127

• Administration of antiemetics may easily control nausea and vomiting.127 b

Administration

For solution and drug compatibility information, see Compatibility under Stability.

IV Administration

Administer IV only by individuals experienced in the administration of the drug.127

Very irritating; must not be given IM, sub-Q, or intrathecally.127 Intrathecal administration usually results in death.127 (See Boxed Warning.)

Management of patients mistakenly receiving intrathecal vinblastine is a medical emergency.127 If administered intrathecally, immediate neurosurgical intervention is required to prevent ascending paralysis leading to death.127 (See Intrathecal Administration under Cautions.)

Administer appropriate quantity of commercially available or reconstituted solution by IV injection into the tubing of a running IV infusion or directly into a vein.127 b

Because of the enhanced possibility of thrombosis, do not inject into an extremity with impaired or potentially impaired circulation caused by compression or invading neoplasm, phlebitis, or varicosity.127 b

Because of possible leukopenic response, administer at intervals of at least 7 days;127 however, even if 7 days have elapsed, do not give next dose until leukocyte count has returned to ≥4000/mm3.127 Strict adherence to recommended dosage interval is important.b

To ensure an adequate trial, therapy must be continued for at least 4–6 weeks.b Some experts advocate a trial of at least 12 weeks, particularly in patients with carcinomas.b

Extremely important to ensure that the needle or catheter is securely within the vein in order to avoid extravasation.127

The manufacturers recommend rinsing the syringe and needle with venous blood after administration of the drug and before withdrawal of the needle to further minimize the possibility of extravasation.127 b

If leakage occurs, discontinue injection immediately and administer remainder of the dose through another vein; local treatment of the area of leakage may minimize discomfort and the possibility of cellulitis.b (See Boxed Warning and also see Local Effects under Cautions.)

Reconstitute powder for injection by adding 10 mL of bacteriostatic sodium chloride injection containing benzyl alcohol as a preservative or 10 mL of sodium chloride injection (without preservatives) to a vial labeled as containing 10 mg of the drug to provide a solution containing 1 mg/mL.127

Do not use other diluents; do not combine with any other chemical.127

To minimize the risk of extravasation and/or venous irritation, do not dilute in large volumes of IV solution (e.g., 100–250 mL).127

Inject appropriate quantity of commercially available or reconstituted solution into the tubing of a running IV infusion or directly into a vein over about a 1-minute period.b

To minimize risk of extravasation and/or venous irritation, do not infuse over long periods of time (i.e., from 30–60 minutes or longer).127

When dispensing, must label syringe or container holding the individual dose with the statement: “Warning: Fatal if given intrathecally. For intravenous use only.”127

Enclose container or syringe holding the individual dose in an overwrap (e.g., plastic bag or similar wrap with typed label) bearing the statements: “Do not remove covering until moment of injection. Fatal if given intrathecally. For intravenous use only.”127 (See Intrathecal Administration under Cautions.)

Consider additional measures to prevent inadvertent intrathecal administration, including: administering diluted vinblastine solutions in minibags; preparing the medication at the time of administration; attaching a unique filter; dispensing separately from all other medications; dispensing directly to the individual who is administering the drug; conducting an independent check of the dose and route of administration for the drug both at the time of preparation and prior to administration; and administering vinblastine in a separate room from rooms where intrathecal medications are administered.225

Dosage

Available as vinblastine sulfate; dosage expressed in terms of the salt.127

Dosage varies depending on the schedule used and whether vinblastine is administered as a single agent or incorporated within a particular chemotherapeutic regimen.127 Consult published protocols for dosages in combination regimens.b

Use of small daily doses for prolonged periods (even if equivalent to the total weekly dosage) is not recommended because it has produced severe toxicity with little or no added therapeutic benefit.b

Pediatric Patients

Some evidence indicates that the usual initial pediatric dosage varies depending on the schedule used and whether vinblastine is administered as a single agent or incorporated within a particular chemotherapeutic regimen.127

In combination with other chemotherapeutic agents, an initial dosage of 6 mg/m2 has been used.127 Adjust dosage based on hematologic tolerance.127 Consult published protocols for additional information on dosage.

An initial dosage of 3 mg/m2 has been used in a combination regimen.127 Adjust dosage based on hematologic tolerance.127 Consult published protocols for additional information on dosage.

As monotherapy, an initial dosage of 6.5 mg/m2 reportedly has been used.127 Adjust dosage based on hematologic tolerance.127 Consult published protocols for additional information on dosage.

Adults

Initially, 3.7 mg/m2 given as a single dose.127

Determine subsequent dosage by clinical and hematologic response and patient tolerance to obtain optimum therapeutic results with minimum adverse effects.127

Increase dosage at weekly intervals in increments of about 1.8–1.9 mg/m2 until desired therapeutic response is obtained, the leukocyte count decreases to about 3000/mm3, or a maximum weekly dose of 18.5 mg/m2 is reached.127

In most adults, the optimum weekly dose will be 5.5–7.4 mg/m2; however, leukopenia (leukocyte count of 3000/mm3) may occur in some patients with 3.7 mg/m2 per week, whereas other patients may tolerate 11.1–18.5 mg/m2 per week.127

Once the dose required to produce a leukocyte count of 3000/mm3 has been determined, administer a maintenance dose of one increment (1.8 mg/m2) less than this amount (e.g., the maximum dose that does not cause leukopenia) at weekly intervals.127

Dosage generally is reduced in patients with recent exposure to radiation therapy or chemotherapy; single doses in these patients usually do not exceed 5.5 mg/m2.b

Duration of maintenance therapy varies according to disease being treated and combination of chemotherapeutic agents being used; there are differences of opinion regarding duration of maintenance therapy with the same protocol for a particular disease.127

Prolonged chemotherapy for maintaining remissions involves several risks (i.e., life-threatening infectious diseases, sterility, possible appearance of other neoplasms resulting from immune system suppression).127

In some disorders, survival following complete remission may not be as prolonged as that achieved with shorter periods of maintenance therapy; however, failure to provide maintenance therapy in some patients may lead to unnecessary relapse.127

Prescribing Limits

Adults

Maximum 18.5 mg/m2 weekly.127

Special Populations

Hepatic Impairment

In patients with a direct serum bilirubin >3 mg/dL, dosage reduction of 50% recommended.127

Renal Impairment

No dosage reduction recommended.127

Metabolized by CYP3A.127 185

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP3A: potential pharmacokinetic interaction (inhibition of vinblastine metabolism); earlier onset and/or increased severity of adverse effects of vinblastine may occur.127 Use concomitantly with caution.127 185

Ototoxic Drugs

Since varying degrees of permanent or temporary hearing impairment associated with eighth cranial nerve damage have been reported in patients receiving vinca alkaloids, use concomitantly with other potentially ototoxic drugs with extreme caution.127 (See Specific Drugs under Interactions.)

Specific Drugs

Vinblastine belongs to the group of medicines known as antineoplastic agents. It is used to treat certain kinds of cancer, including lymphoma and cancer of the breast or testicles, as well as some noncancerous conditions.

Vinblastine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by vinblastine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, such as hair loss, may not be serious but may cause concern. Some effects do not occur until months or years after the medicine is used.

Before you begin treatment with vinblastine, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Vinblastine is to be administered only by or under the immediate supervision of your doctor.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -Most experts consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. -It is probably impractical to resume breastfeeding after therapy with this drug is discontinued because of its long half-life. -Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk. -Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.