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Drug overview for PORTRAZZA (necitumumab):
Generic name: NECITUMUMAB (NE-si-TOOM-oo-mab)
Drug class: Antineoplastic - EGFR Inhibitors, Monoclonal Antibodies
Therapeutic class: Antineoplastics
Necitumumab, a recombinant, fully human IgG1 kappa monoclonal antibody that binds to human epidermal growth factor receptor (EGFR), is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: NECITUMUMAB (NE-si-TOOM-oo-mab)
Drug class: Antineoplastic - EGFR Inhibitors, Monoclonal Antibodies
Therapeutic class: Antineoplastics
Necitumumab, a recombinant, fully human IgG1 kappa monoclonal antibody that binds to human epidermal growth factor receptor (EGFR), is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for PORTRAZZA (necitumumab) have been approved by the FDA:
Indications:
Squamous cell carcinoma of lung
Professional Synonyms:
Epidermoid carcinoma of lung
SCC of lung
Squamous cell lung carcinoma
Squamous non-small cell lung cancer
Squamous NSCLC
Indications:
Squamous cell carcinoma of lung
Professional Synonyms:
Epidermoid carcinoma of lung
SCC of lung
Squamous cell lung carcinoma
Squamous non-small cell lung cancer
Squamous NSCLC
The following dosing information is available for PORTRAZZA (necitumumab):
No enhanced Dosing information available for this drug.
Necitumumab is administered by IV infusion over 60 minutes; the infusion solution should be administered using an infusion pump. Diluted necitumumab infusion solution should not be administered in the same IV line with any other drug or electrolytes. The IV line should be flushed with 0.9%
sodium chloride injection at the end of the infusion. Necitumumab injection concentrate must be diluted prior to administration. Prior to dilution, the injection concentrate should be inspected visually for particulate matter and discoloration.
The injection concentrate should be clear to slightly opalescent and colorless to slightly yellow and should not be used if particulate matter or discoloration is present. Necitumumab is diluted by adding the appropriate volume of necitumumab injection concentrate (containing 16 mg/mL) to an infusion container containing the appropriate volume of 0.9% sodium chloride injection to yield a final volume of 250 mL.
Necitumumab injection concentrate should not be diluted with solutions containing dextrose or other solutions. Necitumumab also should not be admixed with any other drug or electrolytes. The diluted necitumumab infusion solution should be mixed by gentle inversion and should not be shaken.
Diluted necitumumab infusion solution may be stored at room temperature (up to 25degreesC) for up to 4 hours or under refrigeration (2-8degreesC) for up to 24 hours; the diluted infusion solution should not be frozen. Diluted necitumumab infusion solution should be inspected visually for particulate matter and discoloration prior to administration; if particulate matter or discoloration is evident, the diluted solution should be discarded. Any unused portion left in the vial should be discarded since necitumumab injection concentrate contains no preservative. Unopened vials of necitumumab injection concentrate should be protected from light and stored in the original carton at 2-8degreesC, and should not be frozen or shaken.
sodium chloride injection at the end of the infusion. Necitumumab injection concentrate must be diluted prior to administration. Prior to dilution, the injection concentrate should be inspected visually for particulate matter and discoloration.
The injection concentrate should be clear to slightly opalescent and colorless to slightly yellow and should not be used if particulate matter or discoloration is present. Necitumumab is diluted by adding the appropriate volume of necitumumab injection concentrate (containing 16 mg/mL) to an infusion container containing the appropriate volume of 0.9% sodium chloride injection to yield a final volume of 250 mL.
Necitumumab injection concentrate should not be diluted with solutions containing dextrose or other solutions. Necitumumab also should not be admixed with any other drug or electrolytes. The diluted necitumumab infusion solution should be mixed by gentle inversion and should not be shaken.
Diluted necitumumab infusion solution may be stored at room temperature (up to 25degreesC) for up to 4 hours or under refrigeration (2-8degreesC) for up to 24 hours; the diluted infusion solution should not be frozen. Diluted necitumumab infusion solution should be inspected visually for particulate matter and discoloration prior to administration; if particulate matter or discoloration is evident, the diluted solution should be discarded. Any unused portion left in the vial should be discarded since necitumumab injection concentrate contains no preservative. Unopened vials of necitumumab injection concentrate should be protected from light and stored in the original carton at 2-8degreesC, and should not be frozen or shaken.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for PORTRAZZA (necitumumab):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Ropeginterferon alfa-2b/Slt Immunosuppress; Immunomodulator SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ropeginterferon alfa-2b and immunosuppressives both suppress the immune system. CLINICAL EFFECTS: Concurrent use of ropeginterferon alfa-2b with immunosuppressives may result in an increased risk of serious infections. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid concurrent use of myelosuppressive agents.(1-2) If concurrent use cannot be avoided, monitor for effects of excessive immunosuppression. DISCUSSION: In clinical trials, 20% of patients experienced leukopenia. Interferon alfa products may cause fatal or life-threatening infections.(1-2) |
BESREMI |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| COVID-19 Vaccines/Immunosuppressives; Immunomodulators SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Immunosuppressants and immunomodulators may prevent the immune system from properly responding to the COVID-19 vaccine.(1,2) CLINICAL EFFECTS: Administration of a COVID-19 vaccine with immunosuppressants or immunomodulators may interfere with vaccine-induced immune response and impair the efficacy of the vaccine. However, patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: In an effort to optimize COVID-19 vaccine response, the American College of Rheumatology (ACR) published conditional recommendations for administration of COVID-19 vaccines with immunosuppressants and immunomodulators.(1) The CDC also provides clinical considerations for COVID-19 vaccination in patients on immunosuppressants.(2) The CDC states that all immunocompromised patients over 6 months of age should receive at least 1 dose of COVID-19 vaccine if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for specific recommendations based on age, vaccination history, and vaccine manufacturer.(2) The ACR states that in general, immunosuppressants and immunomodulators should be held for 1-2 weeks after each vaccine dose. See below for specific recommendations for certain agents.(1) The CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy.(2) Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted.(1,2) B-cell depleting agents, including rituximab: The ACR recommends consulting with the rheumatologist to determine optimal timing of COVID-19 vaccination. Measuring CD19 B cells may be considered to determine need for a booster vaccine dose. If B cell levels are not measured, a supplemental vaccine dose 2-4 weeks before the next scheduled dose of rituximab is recommended.(1) The CDC states that the utility of B-cell quantification to guide clinical care is not known and is not recommended. Patients who receive B-cell depleting therapy should receive COVID-19 vaccines about 4 weeks before the next scheduled dose. For patients who received 1 or more doses of COVID-19 vaccine during treatment with B-cell-depleting therapies that were administered over a limited period (e.g., as part of a treatment regimen for certain malignancies), revaccination may be considered. The suggested interval to start revaccination is about 6 months after completion of the B-cell-depleting therapy.(2) Abatacept: - Subcutaneous abatacept should be withheld for 1-2 weeks after each vaccine dose, as disease activity allows. - For intravenous abatacept, time administration so that vaccination will occur 1 week before the next abatacept infusion.(1) Cyclophosphamide: When feasible, administer cyclophosphamide one week after each COVID-19 vaccine dose.(1) Recipients of hematopoietic cell transplant or CAR-T-cell therapy who received one or more doses of COVID-19 vaccine prior to or during treatment should undergo revaccination following the current CDC recommendations for unvaccinated patients. Revaccination should start at least 3 months (12 weeks) after transplant or CAR-T-cell therapy.(2) TNF-alpha inhibitors and cytokine inhibitors: The ACR was not able to reach consensus on whether to modify dosing or timing of these agents with COVID-19 vaccination.(1) The CDC includes these agents in their general recommendation to hold therapy for at least 2 weeks following vaccination.(2) DISCUSSION: The ACR convened a COVID-19 Vaccine Guidance Task Force to provide guidance on optimal use of COVID-19 vaccines in rheumatology patients. These recommendations are based on limited clinical evidence of COVID-19 vaccines in patients without rheumatic and musculoskeletal disorders and evidence of other vaccines in this patient population.(1) The ACR recommendation for rituximab is based on studies of humoral immunity following receipt of other vaccines. These studies have uncertain generalizability to vaccination against COVID-19, as it is unknown if efficacy is attributable to induction of host T cells versus B cell (antibody-based) immunity.(1) The ACR recommendation for mycophenolate is based on preexisting data of mycophenolate on non-COVID-19 vaccine immunogenicity. Emerging data suggests that mycophenolate may impair SARS-CoV-2 vaccine response in rheumatic and musculoskeletal disease and transplant patients.(1) The ACR recommendation for methotrexate is based on data from influenza vaccines and pneumococcal vaccines with methotrexate.(1) The ACR recommendation for JAK inhibitors is based on concerns related to the effects of JAK inhibitors on interferon signaling that may result in a diminished vaccine response.(1) The ACR recommendation for subcutaneous abatacept is based on several studies suggesting a negative effect of abatacept on vaccine immunogenicity. The first vaccine dose primes naive T cells, naive T cell priming is inhibited by CTLA-4, and abatacept is a CTLA-4Ig construct. CTLA-4 should not inhibit boosts of already primed T cells at the time of the second vaccine dose.(1) |
COMIRNATY 2024-2025, MODERNA COVID 24-25(6M-11Y)EUA, NOVAVAX COVID 2024-2025 (EUA), PFIZER COVID 2024-25(5-11Y)EUA, PFIZER COVID 2024-25(6M-4Y)EUA, SPIKEVAX 2024-2025 |
The following contraindication information is available for PORTRAZZA (necitumumab):
Drug contraindication overview.
The manufacturer states there are no contraindications to the use of necitumumab.
The manufacturer states there are no contraindications to the use of necitumumab.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 5 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Hypocalcemia |
| Hypokalemia |
| Hypomagnesemia |
| Pregnancy |
| Thromboembolic disorder |
There are 0 moderate contraindications.
The following adverse reaction information is available for PORTRAZZA (necitumumab):
Adverse reaction overview.
Adverse effects reported in at least 15% of patients receiving necitumumab in combination with gemcitabine and cisplatin in the primary efficacy study and at an incidence more than 2% higher than that reported with gemcitabine and cisplatin alone include rash, vomiting, diarrhea, and acneiform dermatitis. Laboratory abnormalities reported in more than 10% of patients receiving necitumumab in combination with gemcitabine and cisplatin in the primary efficacy study and at an incidence more than 2% higher than that reported with gemcitabine and cisplatin alone include hypomagnesemia, hypokalemia, hypocalcemia, and hypophosphatemia.
Adverse effects reported in at least 15% of patients receiving necitumumab in combination with gemcitabine and cisplatin in the primary efficacy study and at an incidence more than 2% higher than that reported with gemcitabine and cisplatin alone include rash, vomiting, diarrhea, and acneiform dermatitis. Laboratory abnormalities reported in more than 10% of patients receiving necitumumab in combination with gemcitabine and cisplatin in the primary efficacy study and at an incidence more than 2% higher than that reported with gemcitabine and cisplatin alone include hypomagnesemia, hypokalemia, hypocalcemia, and hypophosphatemia.
There are 10 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Hypocalcemia Hypokalemia Hypomagnesemia Hypophosphatemia Maculopapular rash |
Hemoptysis Pulmonary thromboembolism Venous thrombosis |
| Rare/Very Rare |
|---|
|
Induration of skin Thrombophlebitis |
There are 19 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acneiform eruption Diarrhea Erythema Skin rash Vomiting |
Acne vulgaris Conjunctivitis Dry skin Dysphagia Headache disorder Mouth irritation Muscle spasm Paronychia Pharyngitis Phlebitis after infusion Pruritus of skin Skin fissure Stomatitis Weight loss |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for PORTRAZZA (necitumumab):
Safety and efficacy of necitumumab have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Based on animal studies and its mechanism of action, necitumumab may cause fetal harm if administered to pregnant women. (See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Other Warnings and Precautions, in Cautions.)
It is not known whether necitumumab is distributed into human milk. The effects of the drug on nursing infants and on milk production also are unknown. Because of the potential for serious adverse reactions to necitumumab in nursing infants, women should be advised not to breast-feed while receiving the drug and for 3 months after the last dose.
In the principal efficacy study evaluating necitumumab in patients with metastatic squamous NSCLC, 39% of patients were 65 years of age or older and 20% were 70 years of age or older. In a subgroup analysis of this study, an overall survival benefit was not observed in patients 70 years of age or older receiving necitumumab in combination with gemcitabine and cisplatin. Although the overall safety of necitumumab was generally similar for subgroups of patients younger than 70 years of age and those 70 years of age or older, a higher incidence of venous thromboembolic events, including pulmonary embolism, was observed in patients 70 years of age or older receiving necitumumab with gemcitabine plus cisplatin compared with younger patients in this study. In a population pharmacokinetic analysis, patient age (range: 19-84 years) did not substantially affect systemic exposure of necitumumab.
The following prioritized warning is available for PORTRAZZA (necitumumab):
WARNING: Rarely, heart problems (cardiopulmonary arrest) or sudden death have occurred in people treated with necitumumab. Before starting treatment with this medication, tell your doctor if you have a history of heart disease (such as heart failure, irregular heartbeat, previous heart attack). Get medical help right away if you develop chest/jaw/left arm pain, shortness of breath, or unusual sweating. Your doctor will order certain blood tests (such as magnesium, calcium, and potassium) during and after your treatment to monitor and help decrease your risk for heart problems.
WARNING: Rarely, heart problems (cardiopulmonary arrest) or sudden death have occurred in people treated with necitumumab. Before starting treatment with this medication, tell your doctor if you have a history of heart disease (such as heart failure, irregular heartbeat, previous heart attack). Get medical help right away if you develop chest/jaw/left arm pain, shortness of breath, or unusual sweating. Your doctor will order certain blood tests (such as magnesium, calcium, and potassium) during and after your treatment to monitor and help decrease your risk for heart problems.
The following icd codes are available for PORTRAZZA (necitumumab)'s list of indications:
| Squamous cell carcinoma of lung | |
| C34 | Malignant neoplasm of bronchus and lung |
| C34.0 | Malignant neoplasm of main bronchus |
| C34.00 | Malignant neoplasm of unspecified main bronchus |
| C34.01 | Malignant neoplasm of right main bronchus |
| C34.02 | Malignant neoplasm of left main bronchus |
| C34.1 | Malignant neoplasm of upper lobe, bronchus or lung |
| C34.10 | Malignant neoplasm of upper lobe, unspecified bronchus or lung |
| C34.11 | Malignant neoplasm of upper lobe, right bronchus or lung |
| C34.12 | Malignant neoplasm of upper lobe, left bronchus or lung |
| C34.2 | Malignant neoplasm of middle lobe, bronchus or lung |
| C34.3 | Malignant neoplasm of lower lobe, bronchus or lung |
| C34.30 | Malignant neoplasm of lower lobe, unspecified bronchus or lung |
| C34.31 | Malignant neoplasm of lower lobe, right bronchus or lung |
| C34.32 | Malignant neoplasm of lower lobe, left bronchus or lung |
| C34.8 | Malignant neoplasm of overlapping sites of bronchus and lung |
| C34.80 | Malignant neoplasm of overlapping sites of unspecified bronchus and lung |
| C34.81 | Malignant neoplasm of overlapping sites of right bronchus and lung |
| C34.82 | Malignant neoplasm of overlapping sites of left bronchus and lung |
| C34.9 | Malignant neoplasm of unspecified part of bronchus or lung |
| C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung |
| C34.91 | Malignant neoplasm of unspecified part of right bronchus or lung |
| C34.92 | Malignant neoplasm of unspecified part of left bronchus or lung |
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