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Danyelza (naxitamab-gqgk)

Buy Danyelza (Naxitamab-gqgk) 40 mg/10 mL | 100% Best Sales

$35,000.00

Danyelza (naxitamab-gqgk) is a prescription medicine used to treat high-risk neuroblastoma (a rare form of cancer) in adults and children at least 1 year old.

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Description

What is Danyelza (naxitamab-gqgk) for?

Danyelza (naxitamab-gqgk) is a GD2-binding monoclonal antibody (immunotherapy) indicated for the treatment of adults and children aged 1 year and older with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow.[1]

It is indicated for use in combination with granulocyte-macrophage colony-stimulating factor (GMCSF) for patients who have achieved partial or minor response or stable disease with prior treatment.[1]

Danyelza is available in injection form containing 40 mg/10 mL naxitamab-gqgk per vial.[1]

How does Danyelza (naxitamab-gqgk) work?

Neuroblastoma is a cancer that grows in the nervous system, outside of the brain. In severe cases, the tumor has spread (metastasized) to the bone or bone marrow.[2]

Danyelza is an antibody, a type of protein, which can bind to the glycolipid GD2. GD2 is found on cells of the central nervous system and nerve cells, in a healthy body. It is overexpressed on neuroblastoma cells and some other tumors.[2]

Binding of the drug to GD2 leads to the destruction of cancer cells (cytotoxicity). It inhibits cell division and in this way causes cancer cells to die.[3]

Where has Danyelza (naxitamab-gqgk) been approved?

Danyelza was approved for the treatment of patients living with refractory relapsed neuroblastoma by:[3]

  • The Food and Drug Administration (FDA), on November 25, 2020.

Danyelza was approved under the accelerated approval regulation, and the FDA granted the medicine Priority Review, Orphan Drug, Breakthrough Therapy, and Rare Pediatric Disease designations.[3]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Danyelza (naxitamab-gqgk) taken?

The standard dosage is:[1]

  • 3 mg/kg body weight

The treatment is given through a needle in the vein (intravenously) once per day on days 1, 3, and 5 of every treatment cycle. The treatment is repeated every four weeks.[1]

The treatment is given in combination with under-the-skin (subcutaneous) injections of GM-CSF.[1] Refer to the GM-CSF Prescribing Information for recommended dosing information.

In the case of adverse reactions, Naxitamab-gqgk and GM-CSF treatment should be modified. Discontinue treatment when the disease worsens or when the patient suffers from too severe side effects.[1]

Pre-infusion medicines and supportive treatment, as appropriate, during infusion can be given.[1]

Warning: Danyelza (naxitamab-gqgk) can cause serious infusion reactions and severe neurotoxicity. Premedicate before starting every treatment as recommended, and permanently stop treatment in case of serious adverse reactions.[1]

Complete information about Danyelza dosage (modifications) and administration can be found in the official prescribing information listed in our references section.[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Danyelza (naxitamab-gqgk)?

Common adverse reactions

The most common side effects (≥20% of patients) listed in the prescribing information include:[1]

  • Pain
  • Infusion-related reaction
  • Swelling of the limbs due to fluid retention (edema)
  • Tiredness (fatigue)
  • Fever
  • Cough
  • Runny nose
  • Increased blood pressure (hypertension) or heart rate (tachycardia)
  • Vomiting
  • Diarrhea
  • Nausea
  • Skin rash
  • Peripheral neuropathy
  • Headache
  • Depressed level of consciousness
  • Neurological disorders of the eye

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:[1]

  • Serious infusion reactions
  • Neurotoxicity

Use in a specific population

Danyelza (naxitamab-gqgk) can cause fetal harm when administered to a pregnant woman, it is advised to avoid pregnancies and breastfeeding.[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.[1]

Neuroblastoma

Indicated, in combination with granulocyte macrophage colony-stimulating factor (GM-CSF), for relapsed or refractory high-risk neuroblastoma in the bone or bone marrow in patients who have demonstrated a partial response, minor response, or stable disease with prior therapy

GM-CSF 250 mcg/m2/day SC on Days -4 to 0, beginning 5 days before infusion

GM-CSF 500 mcg/m2/day SC Days 1 to 5; administer 1 hr before administration

Naxitamab 3 mg/kg/day (up to 150 mg/day) IV on Days 1, 3, and 5; repeat q4Weeks until complete response or partial response, followed by 5 additional cycles q4Weeks

Then repeat q8Weeks for subsequent cycles thereafter

Discontinue naxitamab and GM-CSF for disease progression or unacceptable toxicity

Dosage Modifications

Infusion-related reactions

  • Grade 2
    • Infusion interruption indicated, but responds promptly to symptomatic treatment (eg, antihistamines, NSAIDs, narcotics, IV fluids); prophylactic medications indicated for ≤24 hr
    • Reduce to 50% of previous rate until recovery to Grade ≤1and monitor closely; gradually increase as tolerated to rate before the event
  • Grade 3
    • Prolonged (eg, delayed response to symptomatic medication and/or interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae
    • Immediately interrupt infusion until recovery to Grade ≤2 and monitor closely
    • Resume at 50% of the rate before the event; gradually increase as tolerated to rate before the event
    • Permanently discontinue if nonresponsive to medical intervention
  • Grade 4
    • Life-threatening consequences (eg, urgent intervention indicated) or Grade 3 or 4 anaphylaxis
    • Permanently discontinue

Pain

  • Grade 3 unresponsive to maximum supportive measures
  • Permanently discontinue

Reversible posterior leukoencephalopathy syndrome (RPLS)

  • All grades: Permanently discontinue

Transverse myelitis

  • All grades: Permanently discontinue

Peripheral neuropathy

  • Grade ≥2 motor neuropathy or Grade 3 or 4 sensory neuropathy
  • Permanently discontinue

Neurological disorders of the eye

  • Grade 2-4
    • Resulting in decreased visual acuity or limiting activities of daily living
    • Withhold until resolution; resume at 50% of the prior dose once resolved
    • If tolerated without recurrence of symptoms, gradually increase to dose prior to onset of symptoms
    • Permanently discontinue if unresolved within 2 weeks or upon recurrence
  • Subtotal or total vision loss
    • Permanently discontinue

Prolonged urinary retention

  • Persisting following discontinuation of opioids: Permanently discontinue

Myocarditis

  • Grade 2 or 3: Withhold, reduce dose or permanently discontinue treatment based on severity and duration
  • Grade 4: Permanently discontinue

Hypertension

  • Grade 3
    • Withhold or pause infusion until recovery to Grade ≤2
    • Resume at 50% of prior rate; if tolerated without recurrence of symptoms, gradually increase to rate prior to onset of symptoms
    • Permanently discontinue if nonresponsive to medical intervention
  • Grade 4
    • Permanently discontinue

Orthostatic hypotension

  • All grades
    • Withhold until recovery to Grade ≤1
    • Resolved within 1 week: Restart at 50% of the prior dose; if tolerated without recurrence of symptoms after completion of next cycle, resume to recommended dose for subsequent cycles
    • Not resolved within 1 week: Permanently discontinue

Other adverse reactions

  • Grade 3
    • Withhold until recovery to Grade ≤2, then resume at same rate
    • Permanently discontinue if not resolved to Grade ≤2 within 2 weeks
  • Grade 4
    • Permanently discontinue

Dosing Considerations

Verify pregnancy status in females of reproductive potential before initiation

Adverse Effects

>10% (naxitamab + GM-CSF)

All grades

  • Pain (94-100%)
  • Infusion-related reaction (94-100%)
  • Tachycardia (44-84%)
  • Decreased lymphocytes (74-79%)
  • Decreased hemoglobin (48-76%)
  • Increased glucose (74%)
  • Decreased neutrophils (61-72%)
  • Decreased platelets (65-71%)
  • Decreased albumin (50-68%)
  • Decreased calcium (64%)
  • Decreased potassium (47-63%)
  • Vomiting (60-63%)
  • Cough (57-60%)
  • Nausea (56-57%)
  • Diarrhea (50-56%)
  • Increased ALT (42-55%)
  • Decreased magnesium (54%)
  • Decreased appetite (16-53%)
  • Increased AST (49%)
  • Decreased phosphate (47%)
  • Hypertension (28-44%)
  • Fatigue (28-44%)
  • Decreased sodium (29-38%)
  • Erythema multiforme (33%)
  • Urticaria (32%)
  • Peripheral neuropathy (25-32%)
  • Decreased glucose (29%)
  • Injection site reaction (28%)
  • Edema (2.8-28%)
  • Pyrexia (11-28%)
  • Headache (18-28%)
  • Anxiety (12-26%)
  • Localized edema (25%)
  • Irritability (25%)
  • Rhinorrhea (15-24%)
  • Depressed level of consciousness (24%)
  • Neurological disorders of the eye (19-24%)
  • Hyperhidrosis (17%)
  • Constipation (15%)
  • Oropharyngeal pain (15%)
  • Breath sounds abnormal (15%)
  • Contusion (15%)
  • Lethargy (14%)
  • Rhinovirus infection (12-14%)
  • Enterovirus infection (13%)
  • Anaphylactic reaction (12%)
  • Influenza (12%)
  • Upper respiratory tract infection (12%)
  • Weight decreased (12%)
  • Erythema (11%)

Grades 3 or 4

  • Pain (2.8-72%)
  • Infusion-related reaction (32-68%)
  • Decreased lymphocytes (30-56%)
  • Decreased neutrophils (39-46%)
  • Decreased hemoglobin (4-42%)
  • Decreased platelets (17-40%)
  • Decreased potassium (8-32%)
  • Depressed level of consciousness (16%)
  • Anaphylactic reaction (12%)

1-10% (naxitamab + GM-CSF)

All grades

  • Peripheral edema (8.3%)
  • Apnea (4.2%)
  • Device-related infection (4.2%)
  • Hypopnea (2.8%)

Grades 3 or 4

  • Increased ALT (8-9%)
  • Decreased glucose (8%)
  • Diarrhea (4.2-8%)
  • Headache (8%)
  • Decreased calcium (8%)
  • Decreased albumin (7%)
  • Hypertension (4-7%)
  • Decreased sodium (6%)
  • Decreased phosphate (5%)
  • Decreased appetite (4.2%)
  • Vomiting (2.8-4%)
  • Urticaria (4%)
  • Tachycardia (1.4-4%)
  • Increased AST (4%)
  • Nausea (1.4%)

Warnings

Serious Infusion-Related Reactions

Caution is advised in patients with pre-existing cardiac disease, as this may exacerbate risk of severe hypotension

Serious infusion reactions can occur, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor

Premedicate before each infusion as recommended and monitor for at least 2 hr following completion of each infusion

Reduce rate, interrupt infusion, or permanently discontinue based on severity

Neurotoxicity

Severe neurotoxicity reported, including severe neuropathic pain, transverse myelitis, and RPLS

Premedicate to treat neuropathic pain as recommended

Permanently discontinue based on the adverse reaction and severity

Contraindications

Severe hypersensitivity; including anaphylaxis to naxitamab

Cautions

Serious infusion reactions may occur requiring urgent intervention, including fluid resuscitation, administration of bronchodilators and corticosteroids, intensive care unit admission, infusion rate reduction, or interruption of infusion

Myocarditis reported; monitor for signs and symptoms of myocarditis during treatment; withhold, reduce dose, or permanently discontinue based on severity

Hypertension reported; do not initiate in patients with uncontrolled hypertension; monitor blood pressure during infusion and at least daily on Days 1-8 of each cycle

Fetal harm may occur when administered to pregnant females

Orthostatic hypotension

  • Orthostatic hypotension has occurred in clinical trials and expanded access programs; severe orthostatic hypotension, including cases requiring hospitalization, have occurred; cases occurred within hours to 6 days of infusions in any cycle
  • In patients with symptoms of orthostatic hypotension, monitor postural blood pressure prior to initiating treatment and as clinically indicated with subsequent dosing; withhold, reduce dose, or permanently discontinue therapy based on severity

Neurotoxicity

  • May cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis, and RPLS Pain, including abdominal pain, bone pain, neck pain, and extremity pain occurs in nearly all treated patients
  • Permanently discontinue if transverse myelitis or RPLS occur
  • Peripheral neuropathy, including peripheral sensory neuropathy, peripheral motor neuropathy, paresthesia, and neuralgia reported; permanently discontinue based on severity
  • Neurologic eye disorders reported, including unequal pupils, blurred vision, accommodation disorder, mydriasis, visual impairment, and photophobia
  • Prolonged urinary retention reported on day of infusion (may be related to premedication)

Pregnancy & Lactation

Pregnancy

Based on its mechanism of action, fetal harm may occur when administered to pregnant females

No data available on use in pregnant females and no animal reproduction studies have been conducted

IgG1 monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during third trimester

Advise pregnant females of potential risk to fetus

Verify pregnancy status in females of reproductive potential before initiation

Danyelza Contraception

  • Females of reproductive potential: Use effective contraception during treatment and for 2 months after the final dose

Danyelza Lactation

There are no data on drug presence in human milk or its effects on the breastfed children, or on milk production

However, human IgG is present in human milk

Advise women not to breastfeed during treatment and for 2 months after the final dose

Danyelza 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.

Danyelza Pharmacology

Mechanism of Action

Humanized anti-GD2 3F8 monoclonal antibody; stimulates antibody-dependent cell-mediated cytotoxicity against GD2-expressing tumor cells

GD2, a disialoganglioside with expression in normal tissues restricted primarily to the cerebellum and peripheral nerves, is commonly expressed at high levels on tumors of neuroectodermal origins such as melanomas and neuroblastomas

Danyelza Absorption

Peak plasma concentration: 57.4 mcg/mL

Danyelza Metabolism

Expected to be metabolized into small peptides by catabolic pathways

Danyelza Elimination

Half-life: 8.2 days

Administration

IV Preparation

Visually inspect vial for particulate matter and discoloration before use; solution should appear clear to slightly opalescent and colorless to slightly yellow; discard if solution is discolored, cloudy, or contains particulate matter

Add appropriate quantities of 5% albumin (human) and 0.9% NaCl injection into an empty, sterile IV infusion bag large enough to hold total infusion volume (refer to prescribing information)

Allow for 5-10 min of passive mixing

Withdraw required dose and inject into infusion bag containing the 5% albumin (human) and 0.9% NaCl; discard any unused drug left in vial

Premedication

Danyelza Pain management

  • Initiate prophylactic medication for neuropathic pain (eg, gabapentin) on Days -4 through 7
  • Administer oral opioids 45-60 min before initiating each infusion and additional IV opioids PRN for breakthrough pain during infusion
  • Consider ketamine if pain is not adequately controlled by opioids

Danyelza Prevention of infusion-related reactions and nausea/vomiting

  • Administer IV corticosteroids (eg, methylprednisolone 2 mg/kg [up to 80 mg] or equivalent corticosteroid dose) 30 min to 2 hr before first infusion
  • For subsequent infusions, administer corticosteroids if severe infusion reaction occurred with previous infusion or during previous cycle
  • Administer antihistamine, H2 antagonist, acetaminophen, and antiemetic 30 min before each infusion

Danyelza IV Administration

Administer as diluted IV infusion as recommended; do not administer as IV push or bolus

First infusion (Cycle 1, Day 1): Infuse over 60 min

Subsequent infusion: Infuse over 30-60 min, as tolerated

Following each infusion: Observe patients for at least 2 hr

Danyelza Missed dose

  • Administer missed dose the following week by Day 10
  • Administer GM-CSF 500 mcg/m2/day on the first day of infusion, the day before and the day of the second and third infusion (total of 5 days)

Danyelza Storage

Unopened vials

  • Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light until time of use

Danyelza Diluted infusions

  • If not used immediately, store at room temperature (15-25ºC [59-77ºF]) for up to 8 hr or refrigerate (2-8ºC [36- 46ºF]) for up to 24 hr
  • Once removed from refrigeration, initiate infusion within 8 hr
Danyelza (naxitamab-gqgk)
Danyelza (naxitamab-gqgk)

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