Vektibiks - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Vectibix

Instructions for use:

1. Release form and composition
2. Indications for use
3. Contraindications
4. Method of application and dosage
5. Side effects
6. Special instructions
7. Drug interactions
8. Analogs
9. Terms and conditions of storage
10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 24 700 rub.

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Concentrate for preparation of solution for infusion Vektibix

Vektibix is an antineoplastic agent; monoclonal antibodies.

Release form and composition

Dosage form - concentrate for preparation of solution for infusion: transparent colorless liquid, may contain amorphous protein translucent or white particles (5, 10 or 20 ml in vials, 1 vial in a blister strip, 1 package in a cardboard box).

Active ingredient: panitumumab, in 1 ml of solution - 20 mg.

Auxiliary components: water for injection, glacial acetic acid, sodium chloride, sodium acetate trihydrate.

Indications for use

Vectibix is used for monotherapy of metastatic colorectal cancer with expression of epidermal growth factor receptors (EGF) and non-mutant (wild) type KRAS in case of disease progression during or after the end of the course of chemotherapy with regimens containing irinotecan, oxaliplatin, fluoropyrimidine.

Contraindications

interstitial pneumonitis, pulmonary fibrosis;
pregnancy and breastfeeding;
age up to 18 years;
a history of indication of the development of life-threatening hypersensitivity reactions to any component of the drug.

Method of administration and dosage

Vectibix is injected using an infusion pump intravenously into a peripheral tube or indwelling catheter through an in-line 0.2 or 0.22 μm filter with a low degree of protein binding. The duration of the infusion is approximately 60 minutes, with the appointment of doses above 1000 mg - 90 minutes.

Before administration, the concentrate is diluted in 0.9% sodium chloride solution using aseptic dilution technique. Do not shake and shake the bottle with a solution strongly. The drug should not be administered if it has changed color.

Next, the required amount of Vektibix is taken from the vial to obtain a dose of 6 mg / kg and it is dissolved in a volume of 100 ml. The final concentration of panitumumab should not exceed 10 mg / ml. If a dose of more than 1000 mg is prescribed, it should be dissolved in 150 ml of 0.9% sodium chloride solution. The resulting solution should be mixed by gently inverting the bottle, but not shaking.

Before and after administration of the drug, it is necessary to flush the infusion system in order to prevent mixing panitumumab with other drugs or solutions.

The recommended dose is 6 mg / kg every 2 weeks.

If weak or moderate signs of an infusion reaction appear (1 or 2 degrees), the infusion rate should be halved, with severe symptoms (3 or 4 degrees), the administration should be stopped.

In the case of dermatological reactions of 3 degrees of severity or higher (in accordance with the NCI-CTC / CTCAE classification) or a reaction regarded by the patient as "intolerable", treatment should be temporarily suspended until the severity of the reaction reaches at least 2 degrees of severity. After that, the administration of the drug is resumed at a dose of 50% of the original. If the reactions do not recur, then the dose is gradually (25%) increased until the recommended dose is reached.

If, after skipping 1-2 doses of Vektibix, or with a relapse or an intolerable reaction when using a dose of 50% of the original, the severity of reactions does not decrease at least to 2 degrees of severity, the drug is completely canceled.

Side effects

When using Vektibix as a monopreparation, dermatological reactions occur most often (in 93% of cases). They are usually mild or moderate, and only 12% of cases are severe.

Frequent undesirable effects that occur in more than 20% of patients are disorders of the gastrointestinal tract (nausea, diarrhea, vomiting), pathology of the skin and subcutaneous tissue (itching, erythema, rash, acneiform dermatitis), paronychia, and increased fatigue.

The classification of side effects is presented in accordance with the following gradation of the frequency of their development: very often - ≥1 / 10, often - from ≥ 1/100 to <1/10, rarely - from ≥ 1/1000 to <1/100, very rarely - from ≥ 1/10 000 to <1/1000.

Possible side effects:

infections and invasions: very often - paronychia (usually accompanied by swelling of the lateral nail folds of the fingers and toes); often - eyelid infection, eye infection, pustular rash, cellulitis;
from the respiratory system: very often - cough, shortness of breath; often - nosebleeds, dryness of the nasal mucosa, pulmonary embolism; rarely - bronchospasm;
from the nervous system: often - headache, dizziness;
on the part of the organ of vision: often - hyperemia of the eyeball, increased lacrimation, itching of the eyes, irritation of the eyelids, dryness and irritation of the eyes, increased growth of eyelashes, conjunctivitis;
metabolic disorders: often - hypokalemia, hypocalcemia, hypomagnesemia, dehydration;
from the digestive system: very often - abdominal pain, nausea, stomatitis, diarrhea (with severe diarrhea, dehydration and the development of acute renal failure are possible), constipation, vomiting; often - dryness of the oral mucosa;
on the part of the skin: very often - dryness and peeling of the skin, acne and acne-like rash, skin cracks, exfoliative rash, acneform dermatitis, pruritus, erythema; often - itchy rash, erythematous rash, macular rash, papular rash, maculopapular rash, scabies, skin ulcers, hypertrichosis, palmar-plantar erythrodysesthesia syndrome, alopecia, nail diseases (onychoclasia, onycholysis); very rarely - angioedema; due to severe dermatological reactions, infectious complications may develop, such as local abscesses (requiring surgery and drainage), cellulitis, sepsis (in some cases, fatal);
infusion reactions (usually within 24 hours after infusion): abdominal and back pain, chest pain, bronchospasm, angioedema, anaphylactic reactions, flushing, vomiting, pyrexia, hypotension or hypertension, shortness of breath, tachycardia, chills, cyanosis, cardiac arrest;
others: very often - pyrexia, increased fatigue; often - inflammation of the oral mucosa, hypersensitivity, chills, chest discomfort, tachycardia; rarely - flushing, cyanosis, hypotension or hypertension, anaphylactic reactions.

The most serious side effects when using Vektibix as a single drug or in combination with other antineoplastic agents are: infusion reactions, hypomagnesemia, severe dermatological toxicity complicated by infection, pulmonary embolism, death due to sepsis.

Side effects requiring the cancellation of Vektibix: infusion reactions, severe skin toxicity, paronychia.

special instructions

Treatment with Vektibix should be performed by a physician with experience in the use of anticancer drugs.

Jet and bolus administration of the solution is not recommended.

Determination of the expression of non-mutant KRAS should be performed by experienced laboratory physicians using a validated technique.

During therapy, especially in the case of dermatological reactions or skin rash, it is recommended to use sunscreen and wear a hat, since sunlight can increase the severity of dermatological reactions.

If pulmonary symptoms appear or worsen, treatment should be stopped and symptoms observed immediately and carefully examined. If infiltrates in the lung tissue or pneumonitis are detected, Vektibix should be canceled and appropriate treatment should be prescribed.

It is periodically necessary to monitor the patient's condition for the development of hypomagnesemia and hypocalcemia: once every 2 weeks during the treatment period and within 8 weeks after its termination. In some cases, additional magnesium supplementation may be required. It is also recommended to maintain serum concentrations of other electrolytes.

Patients on a diet with reduced sodium intake should control the amount of sodium in the diet during therapy, since the drug contains 0.15 mmol of sodium, which corresponds to 3.45 mg in 1 ml of concentrate.

Special studies on the effect of Vektibix on the ability to drive and work with complex mechanisms have not been conducted. In the event of side effects from the organ of vision, a decrease in the speed of reaction and the ability to concentrate, one should refrain from activities with potentially dangerous consequences.

Drug interactions

Studies on the interaction of panitumumab have not been conducted.

Combined administration of the drug with chemotherapy regimens containing calcium folinate (leucovorin), fluoropyrimidines or irinotecan is not recommended.

Vectibix is not recommended for use with chemotherapy regimens containing bevacizumab, since no benefits were found with this combination, but there was a significant increase in the incidence of dehydration, electrolyte imbalance, diarrhea, pulmonary embolism and infectious complications, mainly dermatological, as well as an increase in mortality.

Vectibix should not be given in combination with chemotherapy regimens containing oxaliplatin in patients with mCRC (metastatic colorectal cancer), tumors characterized by mutant KRAS (proto-oncogene, a member of the Ras protein family), with an unspecified KRAS status of the tumor, because progression-free studies have shown a reduction in survival overall survival time.

Analogs

There is no information on analogues.

Terms and conditions of storage

Store in its original packaging out of the reach of children, protected from light at a temperature of 2-8 ° C (in the refrigerator). Do not freeze.

The shelf life is 3 years.

The preparation contains neither bacteriostatic agents, nor antimicrobial preservatives, therefore, from a microbiological point of view, it should be used immediately after reconstitution. If the dilution was carried out under controlled aseptic conditions, it can be stored for 24 hours at a temperature of 2-8 ° C.

Terms of dispensing from pharmacies

Dispensed by prescription.

Vectibix: prices in online pharmacies

Drug name

Price

Pharmacy

Vektibix 20 mg / ml concentrate for solution for infusion 5 ml 1 pc.

RUB 24,700

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Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!