Elzonris

Tagraxofusp.

Clear, colourless liquid. A few white to translucent particles may be present.
1 mL of concentrate for solution for infusion contains 1000 mcg tagraxofusp. Each vial contains 1000 mcg of tagraxofusp.
Tagraxofusp is a diphtheria toxin-interleukin-3 (IL-3) fusion protein produced by recombinant DNA technology in Escherichia coli.
Excipient with known effect: Each vial contains 50 mg of sorbitol.
Excipients/Inactive Ingredients: Tromethamine base (Tris) buffer, Sodium chloride, Sorbitol, Hydrochloric acid, Sodium hydroxide, Water for injections.

Pharmacotherapeutic group: Antineoplastic agents; other antineoplastic agents. ATC code: L01XX67.
Pharmacology: Pharmacodynamics: Mechanism of action: Tagraxofusp is a CD123-directed cytotoxin composed of recombinant human interleukin-3 (IL-3) and truncated diphtheria toxin (DT) fusion protein that targets CD123-expressing cells. Tagraxofusp irreversibly inhibits protein synthesis of target cells by inactivating elongation factor 2 (EF2), resulting in apoptosis (cell death).
Clinical efficacy and safety: Study STML-401-0114 was a multi-stage (stage 1 dose escalation, stage 2 expansion, stage 3 confirmatory, stage 4 continued access), non-randomised, open-label, multi-centre study of ELZONRIS. ELZONRIS was administered to 65 previously-untreated and 19 previously treated adult patients with BPDCN according to the WHO classification who received a 12 mcg/kg dose on days 1-5 of multiple 21-day cycles (Table 1). Patients who had known active or suspected CNS leukaemia were not included in the study. The primary endpoint was the rate of complete response (CR; complete resolution of the disease)/clinical complete response (CRc; CR with residual skin abnormality not indicative of active disease). Across all 65 previously untreated patients ELZONRIS resulted in a CR/CRc rate of 56.9% (95% CI: 44.0, 69.2), this included 13 patients in the confirmatory efficacy cohort where the CR/CRc rate was 53.8% (95% CI: 25.1, 80.8). (Table 2).
Patient baseline characteristics are presented in Table 1 and key efficacy measures in Table 2. (See Tables 1 and 2.)

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Click on icon to see table/diagram/image

Pharmacokinetics: The pharmacokinetics of tagraxofusp has been evaluated in 43 patients with BPDCN. Most patients (n=38) had pre-existing anti-drug antibodies (ADA) against the diphtheria toxin (DT) component, due to previous vaccination. Pre-existing ADAs resulted in higher clearance and lower tagraxofusp concentrations. During treatment, all patients developed high ADA titres, and substantially reduced free tagraxofusp levels (see as follows). All data referred to as follows are based on free tagraxofusp concentrations in BPDCN patients without pre-existing anti-drug antibodies (ADA, n=5) in the first treatment cycle. Descriptive information is included for BPDCN patients with pre-existing ADAs (n=38).
Distribution: Following administration of ELZONRIS 12 mcg/kg via 15-minute infusion in patients with BPDCN without pre-existing anti-drug antibodies (ADA, N=5), the mean (SD) unbound area under the plasma drug concentration over time curve (AUC_unbound) of free tagraxofusp on Day 1 of the first cycle of treatment (C1D1) was 230 (123) hr*mcg/L and maximum unbound plasma concentration (C_max) was 162 (58.1) mcg/L.
The mean (SD) volume of distribution of free tagraxofusp on C1D1 was 5.1 (1.9) L in 4 patients with BPDCN without pre-existing ADA.
Elimination: Tagraxofusp is expected to be degraded into peptides and its constituent amino acids through proteolysis, with no involvement of CYP or transporters.
The mean (SD) clearance of free tagraxofusp at C1D1 was 7.1 (7.2) L/hr in 4 patients with BPDCN without pre-existing ADA, and the mean (SD) terminal half-life of tagraxofusp was 0.7 (0.3) hours.
Anti-drug antibody formation affecting pharmacokinetics: Patients with pre-existing ADA had lower unbound tagraxofusp plasma concentrations (AUC and C_max) at C1D1 than patients without pre-existing ADA. Due to the limitation of the bioanalytical method in the presence of ADA, quantitative pharmacokinetic parameters in these patients cannot be given.
Pharmacokinetic/pharmacodynamic relationship: Data collected during Cycle 3 showed increased titres of ADAs and substantially reduced free tagraxofusp concentrations. However, clinical efficacy has been demonstrated beyond Cycle 1 despite the reduced exposure. Due to the limitation of the bioanalytical method, the utility of free tagraxofusp concentrations as a predictor of response is limited.
Pharmacokinetics in special populations: Due to the limitation of the bioanalytical method, the pharmacokinetics of tagraxofusp in patients with renal or hepatic impairment and the effect of body weight, age, and gender are considered unknown.
Paediatric population: The pharmacokinetics of tagraxofusp have not been studied in the paediatric population.
Toxicology: Preclinical safety data: Carcinogenicity or genotoxicity studies have not been performed with tagraxofusp. Tagraxofusp is a recombinant protein and is therefore not expected to interact directly with DNA.
At human equivalent doses greater than or equal to 1.6 times the recommended dose based on body surface area, severe kidney tubular degeneration/necrosis was observed in cynomolgus monkeys. At human equivalent doses equal to the recommended dose, degeneration/necrosis of the choroid plexus in the brain was observed in cynomolgus monkeys. These findings were generally noted after 5 days of daily dosing. The reversibility of this finding was not assessed at lower doses, but the finding was irreversible and became progressively more severe at a human equivalent dose 1.6 times the recommended dose, 3 weeks after dosing stopped. These findings in kidney and choroid plexus are considered likely relevant for the clinical situation.
No fertility studies have been conducted with tagraxofusp. A literature-based risk assessment suggests that exposure to exogenous IL-3 or blockade of IL-3 signaling may have embryotoxic effects on foetal haematopoiesis and embryo-foetal development. The effects of diphtheria toxin exposure on placental and embryo-foetal development are unknown.

ELZONRIS is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) (see Pharmacology: Pharmacodynamics under Actions).

ELZONRIS should be administered under the supervision of a physician experienced in the use of anti-cancer agents. Appropriate resuscitation equipment should be available.
Posology: The recommended dose is 12 mcg/kg tagraxofusp administered as an intravenous infusion over 15 minutes, once daily, on days 1-5 of a 21-day cycle. The dosing period may be extended for dose delays up to day 10 of the cycle. Treatment should be continued until disease progression or unacceptable toxicity (see Precautions).
First treatment cycle: The first cycle of ELZONRIS should be administered in the in-patient setting. Patients should be monitored for signs and symptoms of hypersensitivity or capillary leak syndrome (see Precautions) until at least 24 hours after the last infusion.
Subsequent treatment cycles: ELZONRIS can be administered in the in-patient setting or in a suitable out-patient ambulatory care setting that is equipped for intensive monitoring of patients with haematopoietic malignancies undergoing treatment.
Pre-medication: Patients should be pre-medicated with a H1-histamine antagonist (e.g. diphenhydramine hydrochloride), a H2-histamine antagonist, a corticosteroid (e.g. 50 mg intravenous methylprednisolone or equivalent) and paracetamol approximately 60 minutes prior to the start of infusion (see Precautions).
Dose adjustments: Vital signs should be monitored and albumin, transaminases, and creatinine checked prior to preparing each dose of ELZONRIS. See Table 3 for recommended dose modifications and Table 4 for capillary leak syndrome (CLS) management guidelines.
Vital signs should be monitored frequently during dosing. (See Tables 3 and 4.)

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Click on icon to see table/diagram/image

Special populations: Renal impairment: No data are available for patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No data are available for patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Elderly: No dose adjustment is required for patients over 65 years of age (see Pharmacology: Pharmacokinetics under Actions). Generally, safety was similar between elderly patients (≥ 65 years of age) and patients less than 65 years of age treated with ELZONRIS.
Paediatric population: The safety and efficacy of ELZONRIS in children and adolescents below 18 years have not been established (see Pharmacology: Pharmacodynamics under Actions).
No data are available.
Method of administration: ELZONRIS is for intravenous use.
The prepared dose of diluted ELZONRIS should be administered via an infusion syringe pump over 15 minutes. The total infusion time should be controlled using an infusion syringe pump to deliver the entire dose and the sodium chloride 9 mg/mL (0.9%) solution for injection within 15 minutes.
ELZONRIS must not be administered as an intravenous push or bolus. It should be administered through a dedicated intravenous line and it must not be mixed with other medicinal products (see Incompatibilities under Cautions for Usage).
Prior to infusion, venous access should be established and maintained with sodium chloride 9 mg/mL (0.9%) solution for injection.
For instructions on preparation and administration of the medicinal product, see Special precautions for disposal and other handling under Cautions for Usage.

There have been no cases of overdose reported with ELZONRIS. In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment provided immediately.

Hypersensitivity to the active substance or to any of the excipients listed in Description.

Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Capillary leak syndrome: Capillary leak syndrome (CLS), including life-threatening and fatal cases have been reported with most events occurring during the first five days of the first cycle of treatment. The most frequent signs and symptoms of CLS included weight increased, hypoalbuminemia and hypotension. The incidence of weight increased, hypoalbuminemia, hypotension, and blood alkaline phosphatase increased are all higher among patients who experienced CLS compared to patients that did not experience CLS. Renal failure and acute kidney injury have been reported in two patients with BPDCN and in one patient with AML secondary to CLS (see Adverse Reactions).
Before initiating therapy, ensure that the patient has adequate cardiac function and serum albumin ≥ 3.2 g/dL. During treatment, regularly monitor serum albumin levels prior to the initiation of each dose, or more often as clinically indicated. Additionally, assess patients for other signs/symptoms of CLS including weight gain, new onset or worsening oedema, including pulmonary oedema, and hypotension including haemodynamic instability (see Table 4 under Dosage & Administration).
Patients should be made aware of identifying CLS symptoms and when to seek immediate medical attention. Intravenous albumin supplementation and dosing interruptions may be required (see Dosage & Administration).
Hypersensitivity reactions: Severe hypersensitivity reactions have been reported with ELZONRIS. Commonly reported reactions include rash (generalised/maculo-papular); wheezing; pruritus; angioedema; swelling face; and flushing (see Adverse Reactions). Monitor patients for hypersensitivity reactions during treatment. Depending on the severity and the required interventions, temporarily withhold treatment and resume after symptoms have resolved (see Dosage & Administration).
Haematological abnormalities: Thrombocytopenia and neutropenia have been reported in patients treated with ELZONRIS monotherapy (see Adverse Reactions). The majority of events were reported in cycle 1 and cycle 2 of treatment, were not dose-limiting and did not recur in subsequent cycles. Patients should be routinely monitored and treated as clinically indicated.
Tumour lysis syndrome: ELZONRIS can cause tumour lysis syndrome (TLS), which may be fatal as a result of its rapid anti-tumour activity (see Adverse Reactions).
Identify TLS based on clinical presentation and symptoms, including acute renal failure, hyperkalaemia, hypocalcaemia, hyperuricaemia, or hyperphosphataemia from tumour lysis. Patients considered at high risk for TLS due to high tumour burden should be managed as clinically indicated, including correction of electrolyte abnormalities, monitoring of renal function and fluid balance, and administration of supportive care.
Hepatotoxicity: Treatment with ELZONRIS has been associated with elevations in liver enzymes (see Adverse Reactions). Acute hepatic failure and liver encephalopathy has been reported in a patient treated with ELZONRIS at a higher dose (16 mcg/kg). During treatment, regularly monitor ALT and AST levels prior to the initiation of each dose. Temporarily withhold treatment if transaminases rise to greater than 5 times the upper limit of normal and resume treatment when transaminase elevations are ≤ 2.5 times the upper limit of normal (see Dosage & Administration).
Choroid plexus lesions: Choroid plexitis was identified during non-clinical studies (see Pharmacology: Toxicology: Preclinical safety data under Actions). While not observed in clinical studies, if clinical symptoms or signs suggestive of central nervous system (CNS) damage occur, full clinical and neuro-imaging examination, including fundoscopy and brain magnetic resonance imaging, is recommended.
CNS-involved BPDCN: The passage of tagraxofusp through the blood brain barrier is unknown. Other treatment alternatives should be considered if CNS disease is present.
Hereditary fructose intolerence: Patients with hereditary fructose intolerance (HFI) must not be given this medicinal product unless strictly necessary.
A detailed history with regard to HFI symptoms has to be taken of each patient prior to being given this medicinal product.
Sodium sensitivity: This medicinal product contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially 'sodium-free'.
Effects on ability to drive and use machines: ELZONRIS has no or negligible influence on the ability to drive or use machines.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.

Women of childbearing potential/Contraception: In women of childbearing potential, a negative pregnancy test should be obtained within 7 days prior to initiation of therapy. Effective contraception should be used before the first dose is administered and for at least one week after the last dose.
Pregnancy: There are no data from the use of ELZONRIS in pregnant women. Animal reproduction studies have not been conducted with tagraxofusp (see Pharmacology: Toxicology: Preclinical safety data under Actions).
ELZONRIS should not be used during pregnancy unless the clinical condition of the woman requires treatment with tagraxofusp.
Breast-feeding: It is unknown whether tagraxofusp/metabolites are excreted in human milk.
A risk to breast-feeding newborns/infants cannot be excluded.
Breast-feeding should be discontinued during treatment with ELZONRIS and for at least one week after the last dose.
Fertility: No fertility studies have been conducted with tagraxofusp (see Pharmacology: Toxicology: Preclinical safety data under Actions). There are no data on the effect of tagraxofusp on human fertility.

Summary of the safety profile: The most serious adverse reaction that may occur during ELZONRIS treatment is CLS (see Dosage & Administration and Precautions) which was reported in 18% of patients with a median time to onset of CLS of 6 days.
Adverse reactions occurring in ≥ 20% of patients treated with ELZONRIS were hypoalbuminemia, increased transaminases, thrombocytopenia, nausea, fatigue and pyrexia.
Adverse reactions grade 3 and above according to the Common Terminology Criteria for Adverse events (CTCAE) and occurring in > 5% of patients were increased transaminases, thrombocytopenia and anaemia.
Tabulated list of adverse reactions: The adverse reaction frequency is listed by MedDRA System Organ Class (SOC) at the preferred term level. Frequencies of occurrence of adverse reactions are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1000 to < 1/100).
The adverse reactions described in this section were identified in clinical studies of patients with haematologic malignancies (N=176), including 89 patients with BPDCN. In these studies, ELZONRIS was administered as monotherapy at doses of 7 mcg/kg (12/176, 7%), 9 mcg/kg (9/176, 5%) and 12 mcg/kg (155/176, 88%). Incidence and severity of adverse reaction in patients with BPDCN were similar to those of the entire studied population. (See Table 5.)

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Click on icon to see table/diagram/image

Description of selected adverse reactions: Capillary leak syndrome: Capillary leak syndrome was reported in 18% (32/176), with 12% (21/176) Grade 2, 3% (6/176) Grade 3, 1% (2/176) Grade 4, and fatal in 1.7% (3/176). Of the 25 patients that resumed treatment after experiencing an event of CLS, only 1 patient experienced a recurrence of CLS. The median time to onset of CLS was short (6 days), with all but 2 patients experiencing the first onset of CLS in cycle 1. No patient experienced the first onset of CLS after cycle 2. The overall incidence of CLS was similar in patients with BPDCN (20%, 18/89), including 12% (11/89) Grade 2, 2% Grade 3 (2/89), 2% Grade 4 (2/89) and 3 fatal cases (3%). Patients are required to have adequate cardiac function prior to administration of ELZONRIS (see Dosage & Administration and Precautions).
Hepatotoxicity: ALT and AST elevations were reported as adverse reactions in 47% (83/176) and 46% (81/176) of patients treated with ELZONRIS monotherapy, respectively. ≥ Grade 3 ALT and AST increased were reported in 23% (40/176) and 23% (40/176), respectively. Elevated liver enzymes occurred in the majority of patients in cycle 1 and were reversible following dose interruptions (see Precautions). Similar onset time and incidence were observed in patients with BPDCN, with 51% (45/89) of patients experiencing adverse events of ALT and AST elevations, with ≥ Grade 3 ALT and AST increased reported in 28% (25/89) and 29% (26/89) respectively. Two patients with BPDCN met the laboratory criteria for Hy's Law; in both cases the laboratory abnormalities were noted during Cycle 1.
Haematological abnormalities: Thrombocytopenia was reported in 30% (53/176) of patients treated with ELZONRIS monotherapy and in 35% (31/89) of patients with BPDCN. Thrombocytopenia Grade ≥ 3 was reported in 23% (40/176) of patients treated with ELZONRIS monotherapy and in 26% (23/89) of patients with BPDCN. The majority of thrombocytopenia events were reported in cycle 1 and cycle 2 of treatment. Neutropenia was reported in 9% (15/176) of patients treated with ELZONRIS monotherapy and in 11% (10/89) of patients with BPDCN, with events ≥ Grade 3-reported in 6% (11/176) and 8% (7/89), respectively.
Hypersensitivity: Reactions representative of hypersensitivity were reported in 19% (33/176) of patients treated with ELZONRIS monotherapy and in 17% (15/89) of patients with BPDCN, with events ≥ Grade 3 reported in 3% (6/176) and 4% (4/89), respectively (see Precautions).
Immunogenicity: Immune response was evaluated by assessment of serum binding reactivity against tagraxofusp (anti-drug antibodies; ADA) and neutralising antibodies by inhibition of functional activity. Immune response was assessed using two immunoassays. The first assay detected reactivity directed against tagraxofusp (ADA), and the second assay detected reactivity against the interleukin-3 (IL-3) portion of tagraxofusp. Two cell-based assays were used to investigate the presence of neutralising antibodies by inhibition of a cell-based functional activity.
In 190 patients treated with ELZONRIS in four clinical studies: 94% (176/187) of patients evaluable for the presence of pre-existing ADA at baseline before treatment were confirmed positive with 27% being positive for the presence of neutralising antibodies. The high prevalence of ADA at baseline was anticipated due to diphtheria immunisation.
100% (N=170) of patients evaluable for treatment-emergent ADA tested positive with most patients showing an increase in ADA titre by the end of Cycle 2 of ELZONRIS.
92% (155/169) of ADA-positive patients evaluable for the presence of neutralising antibodies post-treatment were neutralising antibody-positive.
75% (129/171) of patients evaluable for treatment-emergent anti-IL-3 antibodies tested positive with most patients testing positive by Cycle 3 of ELZONRIS.
74% (93/126) of patients who tested positive for anti-IL-3 antibodies and were evaluable for the presence of neutralising antibodies were neutralising antibody-positive.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions according to the guideline issued by local authority.

No interaction studies have been performed.

Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handling as follows.
Special precautions for disposal and other handling: General precautions: Procedures for proper handling, including personal protective equipment (e.g. gloves), and disposal of anticancer medicines should be followed.
The solution for infusion should be prepared by a healthcare professional using proper aseptic technique throughout the handling of this medicinal product.
Preparation and administration: Preparing the infusion: Ensure the following components required for dose preparation and administration are available prior to thawing ELZONRIS: One infusion syringe pump; One empty 10 mL sterile vial; Sodium chloride 9 mg/mL (0.9%) solution for injection; Three 10 mL sterile syringes; One 1 mL sterile syringe; One mini-bifuse Y-connector; Microbore tubing; One 0.2 µm low protein binding polyethersulfone in-line filter.
Use only if the solution is clear and colourless or with a few white to translucent particles.
Allow vials to thaw at 25 °C or below for up to 1 hour in the outer carton. Do not refreeze a vial once thawed.
Determining dosage amount: Calculation to determine the total ELZONRIS dose (mL) to be administered (see Dosage & Administration): See equation.

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A 2-step process is required for preparation of the final ELZONRIS dose: Step 1 - Prepare 10 mL of 100 mcg/mL ELZONRIS: Using a sterile 10 mL syringe, transfer 9 mL of sodium chloride 9 mg/mL (0.9%) solution for injection to an empty sterile 10 mL vial.
Gently swirl the ELZONRIS vial to mix the contents, remove the cap, and using a sterile 1 mL syringe, withdraw 1 mL of thawed ELZONRIS from the product vial.
Transfer the 1 mL of ELZONRIS into the 10 mL vial containing the 9 mL of sodium chloride 9 mg/mL (0.9%) solution for injection. Gently invert the vial at least 3 times to mix the contents. Do not shake vigorously.
Following dilution the final concentration of ELZONRIS is 100 mcg/mL.
Step 2 - Prepare the ELZONRIS infusion set: Calculate the required volume of diluted ELZONRIS (100 mcg/mL) according to patient's weight.
Draw up the required volume into a new syringe (if more than 10 mL of diluted ELZONRIS (100 mcg/mL) is required for the calculated patient dose, repeat step 1 with a second vial of ELZONRIS). Label the ELZONRIS syringe.
Prepare a separate syringe with at least 3 mL of sodium chloride 9 mg/mL (0.9%) solution for injection to be used to flush the administration set once the ELZONRIS dose is delivered.
Label the sodium chloride 9 mg/mL (0.9%) solution for injection flush syringe.
Connect the sodium chloride 9 mg/mL (0.9%) solution for injection flush syringe to one arm of the Y-connector and ensure the clamp is closed.
Connect the product syringe to the other arm of the Y-connector and ensure the clamp is closed.
Connect the terminal end of the Y-connector to the microbore tubing.
Remove the cap from the supply side of the 0.2 µm filter and attach it to the terminal end of the microbore tubing.
Unclamp the arm of the Y-connector connected to the sodium chloride 9 mg/mL (0.9%) solution for injection flush syringe. Prime the Y-connector up to the intersection (do not prime the full infusion set with sodium chloride 9 mg/mL (0.9%) solution for injection). Re-clamp the Y-connector line on the sodium chloride 9 mg/mL (0.9%) solution for injection flush arm.
Remove the cap on the terminal end of the 0.2 µm filter and set it aside. Unclamp the arm of the Y-connector connected to the product syringe, and prime the entire infusion set, including the filter. Recap the filter, and re-clamp the Y-connector line on the product side. The infusion set is now ready for delivery for dose administration.
The diluted solution should be used immediately once prepared.
Administration: 1. Establish venous access and maintain with sterile sodium chloride 9 mg/mL (0.9%) solution for injection.
2. Administer the prepared ELZONRIS dose via infusion with an infusion syringe pump over 15 minutes. The total infusion time will be controlled using an infusion syringe pump to deliver the entire dose and the sodium chloride 9 mg/mL (0.9%) solution for injection flush over 15 minutes.
3. Insert the ELZONRIS syringe into the infusion syringe pump, open the clamp on the ELZONRIS side of the Y-connector and deliver the prepared ELZONRIS dose.
4. Once the ELZONRIS syringe has been emptied, remove it from the pump and place the sodium chloride 9 mg/mL (0.9%) solution for injection flush syringe in the infusion syringe pump.
5. Open the clamp on the sodium chloride 9 mg/mL (0.9%) solution for injection flush side of the Y-connector and resume infusion via the infusion syringe pump at the pre-specified flow to push the remaining ELZONRIS dose out of the infusion line to complete delivery.
Disposal: ELZONRIS is for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Shelf life: Unopened vial: 3 years.
After opening: From a microbiological point of view, once opened, the medicinal product should be diluted and infused immediately.
After preparation of solution for infusion: Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Special precautions for storage: Store and transport frozen (-20 °C ± 5 °C).
Do not refreeze after thawing.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see Shelf life as previously mentioned.

Targeted Cancer Therapy

L01XX67 - tagraxofusp ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.

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