Pivekimab sunirine
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) DECNUPAZ can cause hepatotoxicity, including severe or fatal hepatic VOD (also known as sinusoidal obstruction syndrome) [see Warnings and Precautions ( 5.1 )] . Closely monitor patients for signs and symptoms of VOD including elevations in liver tests, hepatomegaly (which may be painful), rapid weight gain, and ascites [see Warnings and Precautions ( 5.1 )] . Monitor liver tests, including ALT, AST, and total bilirubin, prior to each dose of DECNUPAZ [see Warnings and Precautions ( 5.1 )] . Delay DECNUPAZ dosage for liver test elevation.
Permanently discontinue DECNUPAZ for patients who experience VOD [see Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.1 )] . WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) See full prescribing information for complete boxed warning. VOD, a severe form of hepatotoxicity, has been reported in patients with BPDCN treated with DECNUPAZ, including severe or fatal hepatic VOD. ( 5.1 ) Closely monitor for signs and symptoms of VOD. Monitor liver tests and total bilirubin prior to each dose. ( 5.1 ) Discontinue DECNUPAZ for patients who experience VOD. ( 2.4 , 5.1 )
Dosing in kidney impairment
Renal Impairment Avoid use of DECNUPAZ in patients with moderate to severe renal impairment (CLcr <60 mL/min, estimated by Cockcroft-Gault) or patients with end stage renal disease. A higher incidence of Grade ≥3 adverse events, serious adverse events, and dose delays was observed in patients with moderate renal impairment (CLcr 30 to <60 mL/min).
DECNUPAZ has not been studied in patients with severe renal impairment (CLcr <30 mL/min) or end stage renal disease. No dosage adjustment of DECNUPAZ is recommended for patients with mild renal impairment (CLcr 60 to <90 mL/min, estimated by Cockcroft-Gault) [see Clinical Pharmacology] .
Dosing in liver impairment
Hepatic Impairment Avoid use of DECNUPAZ in patients with moderate to severe hepatic impairment (total bilirubin >1.5 x ULN with any AST). Limited data are available in patients with moderate hepatic impairment (total bilirubin >1.5 to 3 times ULN and any AST). DECNUPAZ has not been studied in patients with severe hepatic impairment.
No dosage adjustment of DECNUPAZ is recommended for patients with mild hepatic impairment (total bilirubin ≤ULN and AST >ULN or total bilirubin ≤1.5 times ULN and any AST) [see Clinical Pharmacology] .
Preparation and administration
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Important Administration Instructions DECNUPAZ requires reconstitution followed by two dilutions prior to administration. Read the entire preparation instructions carefully before preparing and administering DECNUPAZ.
Premedications Administer the premedications in Table 1 the day prior to and the day of the infusion of DECNUPAZ to reduce the risk of infusion-related reactions (IRRs) [see Warnings and Precautions] . [See table below.]
Instructions for Preparation [See table below.] Storage of Diluted Solution Immediately use diluted DECNUPAZ solution. The total storage time from the start of dose preparation to completion of administration should not exceed 24 hours. Store the diluted solution of DECNUPAZ under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours, including up to 8 hours at room temperature at 9°C to 25°C (48°F to 77°F), from the time of reconstitution to completion of the intravenous infusion.
Discard diluted infusion solution if storage time exceeds these limits. If refrigerated, allow approximately 30 minutes for the diluted solution to come to room temperature prior to administration. Do not shake. Do not freeze the diluted infusion solution. Protect from light during storage. Do not shake.
Administration After preparing the dose for infusion, visually inspect the syringe content for particulates and discard if present. Do not mix DECNUPAZ with any other drugs or any intravenous fluids other than 5% Dextrose Injection. Protect the intravenous syringe from light using a light-blocking cover during infusion.
The infusion line does not need to be protected from light. Administer DECNUPAZ as an intravenous infusion only. Do not administer as an intravenous push or bolus. The first infusion of DECNUPAZ should be administered at a rate of 0.8 mL/min (0.165 mg/min) for the first 30 minutes. If well tolerated, the infusion rate can be increased after 30 minutes to 1.7 mL/min (0.33 mg/min), if necessary.
Subsequent infusions may be delivered at the highest tolerated rate. Following the infusion, flush the intravenous line with sufficient volume of 5% Dextrose Injection to ensure delivery of the full dose. Do not use any other intravenous fluids for flushing.
| Administration Time Prior to DECNUPAZ Infusion | Premedication | Route of Administration | Dose (or equivalent) |
| Day before DECNUPAZ infusion | Corticosteroid | Oral or intravenous | Dexamethasone 8 mg twice daily |
| 30 to 60 minutes prior to infusion | Corticosteroid | Intravenous | Dexamethasone 8 mg |
| Antihistamine | Intravenous | Diphenhydramine 25 mg to 50 mg | |
| Antipyretic | Oral | Acetaminophen 325 mg to 650 mg |
| Adverse Reaction | Severity of Adverse Reactiona | Dose Modification Guidelines |
| Veno-occlusive disease (VOD) [see Warnings and Precautions (5.1)] | Any Grade | Permanently discontinue DECNUPAZ |
| Increased aspartate aminotransferase (AST) or alanine aminotransferase (ALT) [see Warnings and Precautions (5.1)] | Either AST or ALT is >2.5 x ULN | Delay further DECNUPAZ dosing until AST or ALT have returned to ≤2.5 × ULN |
| Increased bilirubin [see Warnings and Precautions (5.1)] | Total bilirubin > 1.5 × ULN | Delay further DECNUPAZ dosing until total bilirubin has returned to ≤1.5 × ULN |
| Infusion-related reactions [see Warnings and Precautions (5.2)] | Grade 2 | Interrupt DECNUPAZ infusion and institute appropriate medical management After full resolution of symptoms, resume DECNUPAZ infusion at 50% of the previous rate and if no further symptoms appear, increase rate as appropriate until infusion is completed |
| Grade 3 | Stop DECNUPAZ infusion and institute appropriate medical management After full resolution of symptoms, resume the infusion at 50% of the previous rate If symptoms recur, permanently discontinue | |
| Grade 4 | Permanently discontinue DECNUPAZ | |
| Edema [see Warnings and Precautions (5.3)] | Grade 1 (5-10% inter-limb discrepancy in volume or circumference, 4 kg weight gain, or 1+ pitting edema (2 mm)) | Follow weekly weights Consider administering diuretic therapy |
| Grade 2 (10-30% inter-limb discrepancy in volume or circumference, >4 kg weight gain, or 2+ pitting edema (4 mm)) | Administer diuretic therapy Manage hypoalbuminemia as needed Delay further DECNUPAZ dosing until edema has returned to Grade 0-1 or baseline If delayed more than 2 weeks, consider dose reduction before resuming | |
| Grade 3 (> 30% inter-limb discrepancy in volume, or 3+/4+ pitting edema (>6 mm)) | Consider combination diuretic therapy Manage hypoalbuminemia as needed Delay further DECNUPAZ dosing until edema has returned to Grade 0-1 or baseline Consider resuming DECNUPAZ infusion at 0.015 mg/kg intravenously once every 3 weeks | |
| Grade 4 (life threatening) | Permanently discontinue DECNUPAZ | |
| Other Non-hematologic Adverse Reactions [see Adverse Reactions (6.1)] | Grade 3 | Delay further DECNUPAZ dosing until resolved to ≤ Grade 2 or baseline |
| Grade 4 | Permanently discontinue DECNUPAZ |
| PreparationUse aseptic technique to prepare DECNUPAZ. DECNUPAZ is a hazardous drug. Follow applicable special handling and disposal procedures in accordance with local requirements.1 Determine the dose and the number of DECNUPAZ vials needed. More than one vial may be needed to achieve a full dose. Remove the DECNUPAZ vial(s) from the refrigerator and allow the vial(s) to reach room temperature 15°C to 30°C (59℉ to 86°F) before use. |
| Reconstitution Using a sterile syringe, reconstitute DECNUPAZ by slowly injecting 1.1 mL of Sterile Water for Injection into each vial to obtain a concentration of 2 mg/mL. Each single-dose vial contains 1 mL (2 mg) of withdrawable DECNUPAZ. Gently swirl the vial in a circular motion. Do not shake. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted solution in each vial should appear clear to slightly opalescent, colorless to slightly yellow and free of visible contaminants, particles and/or particulates. Do not use if discoloration or particulate matter is present. DECNUPAZ contains no preservative. Use reconstituted solution immediately. If not used immediately, store the reconstituted DECNUPAZ vials in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 4 hours from the time of reconstitution. Do not freeze. |
| First DilutionDECNUPAZ must be diluted with 5% Dextrose Injection. Add 4.8 mL of 5% Dextrose Injection to the reconstituted solution in the vial. Mix the diluted solution by gentle inversion. Do not shake. The resulting diluted solution concentration is 0.4 mg/mL. Calculate the required administration volume needed from the first dilution of vial(s). Volume needed from vial(s) after first dilution (mL) = Dose (mg) / 0.4 mg/mL DECNUPAZ requires a second dilution prior to administration. |
| Second DilutionWithdraw the calculated volume from the first dilution of vial(s) using an appropriately sized syringe. Withdraw an equal volume of 5% Dextrose Injection in an appropriately sized second syringe. Attach a connector to the two syringes and transfer DECNUPAZ into the syringe containing 5% Dextrose Injection. Disconnect the syringes. Draw air into the syringe containing the DECNUPAZ diluted solution and close. Gently invert the syringe to mix the solution. Do not shake. Remove air bubbles from the syringe before administration. The final concentration is 0.2 mg/mL. Discard any unused drug remaining in the vial(s). Do not use an in-line filter due to increased drug loss. If an in-line filter is required, a 1.2 micron polyethersulfone (PES) filter can be used. |
Drug interactions
Check pivekimab sunirine against a medication listLabel text (2 paragraphs)
7. DRUG INTERACTIONS Strong and M oderate CYP3A Inhibitors : Closely monitor for DECNUPAZ adverse reactions ( 7.1 )
7.1 Effect of Other Drugs on DECNUPAZ Strong and moderate CYP3A inhibitors Closely monitor patients for adverse reactions with DECNUPAZ when used concomitantly with strong and moderate CYP3A inhibitors. FGN849 is a substrate of CYP3A [see Clinical Pharmacology ( 12.3 )] . Concomitant use of DECNUPAZ with strong and moderate CYP3A inhibitors may increase unconjugated FGN849 exposure, which may increase the risk of DECNUPAZ adverse reactions.
Contraindications
4. CONTRAINDICATIONS None. None. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for pivekimab sunirine. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on its mechanism of action, DECNUPAZ can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (FGN849) and affects actively dividing cells [see Clinical Pharmacology ( 12.1 ), Nonclinical Toxicology ( 13.1 )] . There are no available data on the use of DECNUPAZ in pregnant women to inform a drug-associated risk. Advise patients of the potential risks to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data Animal Data Animal reproductive or developmental toxicity studies were not conducted with pivekimab sunirine-pvzy. The cytotoxic component of DECNUPAZ, FGN849, is a DNA-alkylating agent that is toxic to rapidly dividing cells, indicating it has the potential to cause embryofetal lethality and teratogenicity.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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