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10/26/2020

Ketorolac Injection

Products Affected - Description

    • Ketorolac injection, Almaject, 15 mg/mL, 1 mL vial, 25 count, NDC 72611-0719-25
    • Ketorolac injection, Almaject, 30 mg/mL, 1 mL vial, 25 count, NDC 72611-0722-25
    • Ketorolac injection, Athenex, 15 mg/mL, 1 mL vial, 25 count, NDC 70860-0700-02
    • Ketorolac injection, Athenex, 30 mg/mL, 1 mL vial, 25 count, NDC 70860-0701-03
    • Ketorolac injection, Athenex, 30 mg/mL, 2 mL vial, 25 count, NDC 70860-0701-04
    • Ketorolac injection, Fresenius Kabi, 15 mg/mL, 1 mL vial, 25 count, NDC 63323-0161-01
    • Ketorolac injection, Fresenius Kabi, 30 mg/mL, 1 mL vial, 25 count, NDC 63323-0162-01
    • Ketorolac injection, Hikma, 15 mg/mL, 1 mL vial, 25 count, NDC 00641-6041-25
    • Ketorolac injection, Hikma, 30 mg/mL, 1 mL vial, 25 count, NDC 00641-6042-25
    • Ketorolac injection, Hikma, 30 mg/mL, 2 mL for intramuscular use vial, 25 count, NDC 00641-6043-25
    • Ketorolac injection, Pfizer, 15 mg/mL, 1 mL vial, 25 count, NDC 00409-3793-01
    • Ketorolac injection, Pfizer, 30 mg/mL, 1 mL Carpuject syringe, 10 count, NDC 00409-2287-31
    • Ketorolac injection, Pfizer, 30 mg/mL, 2 mL for intramuscular use Carpuject syringe, 10 count, NDC 00409-2287-61
    • Ketorolac injection, Sagent, 15 mg/mL, 1 mL vial, 25 count, NDC 25021-0700-01
    • Ketorolac injection, Sagent, 30 mg/mL, 1 mL vial, 25 count, NDC 25021-0701-01
    • Ketorolac injection, Sagent, 30 mg/mL, 2 mL for intramuscular use vial, 25 count, NDC 25021-0701-02

Reason for the Shortage

    • Alvogen did not provide a reason for the shortage.[1]
    • Amphastar has discontinued ketorolac injection.[2]
    • Athenex did not provide reason for the shortage.[3]
    • Baxter did not provide a reason for the shortage.[4]
    • BD RX is now part of Fresenius Kabi.[5]
    • Fresenius Kabi has most ketorolac presentations available.[6]
    • Fosun Pharma has ketorolac available.[10]
    • Pfizer has ketorolac injection on back order due to manufacturing delays.[7]
    • Sagent states the reason for the shortage is manufacturing delay.[8]
    • Hikma did not provide a reason for the shortage.[9]
    • Ben Venue closed its plant in Bedford, Ohio in July 2014.[11]
    • Virtus discontinued ketorolac in March 2019.[12]
    • FDA imposed an import ban in mid-2013 on several Wockhardt products including ketorolac.[13]
    • Sprix Nasal Spray is not affected by this shortage.[14]

Available Products

    • Ketorolac injection, Almaject, 30 mg/mL, 2 mL vial, 25 count, NDC 72611-0725-25
    • Ketorolac injection, Baxter, 15 mg/mL, 1 mL vial, 10 count, NDC 00338-0069-10
    • Ketorolac injection, Baxter, 30 mg/mL, 1 mL vial, 25 count, NDC 00338-0072-25
    • Ketorolac injection, Fosun Pharma, 30 mg/mL, 1 mL vial, 25 count, NDC 72266-0118-25
    • Ketorolac injection, Fosun Pharma, 30 mg/mL, 2 mL vial, 25 count, NDC 72266-0119-25
    • Ketorolac injection, Fresenius Kabi, 15 mg/mL, 1 mL prefilled syringe, 24 count, NDC 76045-0107-10
    • Ketorolac injection, Fresenius Kabi, 30 mg/mL, 1 mL prefilled syringe, 24 count, NDC 76045-0104-10
    • Ketorolac injection, Fresenius Kabi, 30 mg/mL, 2 mL for intramuscular use prefilled syringe, 24 count, NDC 76045-0105-20
    • Ketorolac injection, Fresenius Kabi, 30 mg/mL, 2 mL for intramuscular use vial, 25 count, NDC 63323-0162-02
    • Ketorolac injection, Pfizer, 30 mg/mL, 1 mL vial, 25 count, NDC 00409-3795-01
    • Ketorolac injection, Pfizer, 30 mg/mL, 2 mL for intramuscular use vial, 10 count, NDC 00409-3796-01

Estimated Resupply Dates

    • Almaject has ketorolac 15 mg/mL 1 mL vials on back order and the company estimates a release date of mid-October 2020.1
    • Athenex has ketorolac 15 mg/mL 1 mL vials on back order and the company estimates a release date of early-November 2020. The 30 mg/mL 1 mL vials for intramuscular use are on back order and the company estimates a release date of early-November 2020. The 30 mg/mL 2 mL vials for intramuscular use are on back order and the company cannot estimate a release date.[3]
    • Fresenius Kabi has ketorolac 30 mg/mL 1 mL vials on back order and the company estimates a release date of late-October 2020. The 15 mg/mL 1 mL vials are on back order and the company estimates a release date of late-November to early-December 2020.[6]
    • Hikma has all ketorolac presentations on back order and the company estimates a release date of 4th quarter 2021.[9]
    • Pfizer has ketorolac 30 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of January 2021. The 30 mg/mL 2 mL Carpuject syringes for intramuscular injection are on back order and the company estimates a release date of January 2021. The 15 mg/mL 1 ml vials are available in limited supply.[7]
    • Sagent has ketorolac 15 mg/mL 1 mL vials, 30 mg/mL 1 mL vials, and 30 mg/mL 2 mL vials for intramuscular injection on back order and the company cannot estimate a release date.[8]

Implications for Patient Care

    • Ketorolac is a nonsteroidal anti-inflammatory drug labeled for use in adults with moderate to severe acute pain who require short-term analgesia at the opioid level, typically following surgery.[15] Ketorolac can be used alone, or in combination with opioid analgesics. Ketorolac is useful in situations where opioids are contraindicated or to reduce opioid dosage requirements when used in combination with opioids. Total duration of ketorolac given intravenous, intramuscular, or orally should not exceed 5 days due to the increased frequency and severity of adverse reactions. Ketorolac, given intramuscularly, is used off-label for the management of migraine.[16-17]

Safety

    • Dosage recommendations and administration times vary significantly between alternative agents. Patient harm can occur if these agents are used erroneously. Use extra caution when switching to alternative agents.[15,18-20]

Alternative Agents & Management

    • No single agent can be substituted for ketorolac injection. The choice of alternative agent must be patient-specific, procedure-specific, and based on the clinical situation and other comorbid conditions. Utilize stakeholder clinicians to help make specific plans for individual patient populations.
    • Tables 1 and 2 summarize the differences between some potential alternatives to ketorolac for acute pain. Injectable diclofenac was recently approved by the FDA (December 2014) but the product is not currently available and not included in the tables.[7,15-20]
    • During this shortage, ensure appropriate pain control and explore all therapeutic modalities. Utilize oral and rectal medications whenever possible.
    Table 1. Comparison of Select Non-Opioid Injectable Agents Used for Acute Pain15-18,20-21
    MedicationDescriptionLabeled Indication for AdultsHow SuppliedStorage and HandlingDose Preparation
    KetorolacNonsteroidal anti-inflammatory (NSAID)Moderate to severe pain that requires analgesia at opioid level; for short-term use only (< 5 days).Injection: 15 mg in1 mL single-dose vial or syringe 30 mg in 1 mL single-dose vial or syringe 60 mg in 2 mL single-dose vial (30 mg/mL)

    Intranasal: 15.75 mg/spray

    Oral: 10 mg tablet
    Store at room temperature (20-25 degrees C).

    Protect from light.
    Withdraw the correct dose from vial into appropriate sterile syringe. Discard unused portion of single-dose vials.

    To avoid precipitation, do not mix ketorolac with morphine, meperidine, promethazine, or hydroxyzine in a syringe or other small volume.

    An intravenous bolus is given over 15 seconds.
    Ibuprofen (Caldolor) Cumberland PharmaceuticalsNonsteroidal anti-inflammatoryMild to moderate pain.

    Moderate to severe pain with adjunctive opioids.

    Fever reduction.
    Injection: 100 mg/mL 8 mL single-dose vial

    Oral: multiple presentations
    Diluted solutions stable for <24 hours at room temperature.

    Store unopened vials at room temperature (20-25 degrees C).
    Prior to administration, dilute to < 4mg/mL concentration, in 0.9% sodium chloride injection, 5% dextrose injection, or lactated Ringer's injection.

    Infusion time must be no less than 30 minutes.
    Acetaminophen (Ofirmev) Cadence PharmaceuticalsNon-salicylate, non-opioid agent with antipyretic and analgesic effectsMild to moderate pain.

    Moderate to severe pain with adjunctive opioids.

    Fever reduction.
    Injection: 10 mg/mL 100 mL single use vial

    Oral: multiple presentations

    Rectal: multiple presentations
    Store at room temperature (20-25 degrees C).

    Do not refrigerate or freeze.

    Use within 6 hours of opening the vial.
    Do not mix or administer with other medications.

    Doses of 1000 mg may be given undiluted from original vial using vented IV set.

    Doses of <1000 mg must be withdrawn from original vial and placed in a separate empty container (glass bottle, plastic IV container, or syringe) prior to administration. Discard unused portion of vial.

    Infusion time is 15 minutes.

    Table 2. Comparison of Non-Opioid Injectable Agents Used for Acute Pain: Pharmacokinetic Parameters, Warnings and Contraindications 15-21
    MedicationMean Volume of DistributionMean Half-lifeProtein bindingBlack Box WarningsContraindications
    KetorolacIntravenous: 0.21 L/kg

    Intramuscular: 0.18 L/kg
    Racemate: 5.6 hours (intravenous)

    5.3 hours (oral, intramuscular)

    4.8 hours (intranasal)
    99%Not for minor or chronic pain

    Not for pediatric patients

    Risk of potentially fatal GI bleeding or perforation; elderly patients at increased risk

    Increased risk of potentially fatal cardiovascular thrombotic events, myocardial infarction, and stroke

    Peri-operative pain in CABG surgery

    Renal toxicity risk

    Bleeding risk due to platelet function inhibition

    Not for use prior to major surgery

    Risk of hypersensitivity reactions; must have measures available to treat at first-dose administration

    Contains alcohol, do not administer via intrathecal or epidural routes

    Risk of fetal harm if used during labor and delivery

    Risk to nursing neonate if used by mother

    Risk of additive adverse events if used with other NSAIDs

    Reduce dose in patients >65 years old, patients weighing <50 kg, or patients with elevated serum creatinine. Do not exceed total daily dose of 60 mg injectable ketorolac

    Do not exceed 5 days (combined duration, any route)
    History of allergic reaction to ketorolac, aspirin, or any other NSAID

    Active peptic ulcer disease

    Recent GI bleeding or perforation

    History of GI bleeding or peptic ulcer disease

    Peri-operative pain in CABG surgery

    Advanced renal impairment

    Patients at risk of renal failure resulting from volume depletion

    Cerebrovascular bleeding (suspected or confirmed)

    Hemorrhagic diathesis

    Incomplete hemostasis

    Patients with high risk of bleeding

    Prior to any major surgery

    Intrathecal or epidural administration

    During labor and delivery

    Nursing mothers

    Concomitant use with aspirin or other NSAIDs

    Concomitant use with probenecid or pentoxifylline
    Ibuprofen (Caldolor)Not available2.4 hours>99%Increased risk of potentially fatal cardiovascular thrombotic events, myocardial infarction, and stroke; do not use for CABG surgery peri-operative pain

    Risk of potentially fatal GI bleeding, ulceration, or perforation; elderly patients at increased risk
    Known hypersensitivity to ibuprofen

    History of allergic reactions, asthma, or urticaria with aspirin or any other NSAID

    Peri-operative pain in CABG surgery
    Acetaminophen(Ofirmev)Intravenous: 0.8 L/kg2.4 hours10 to 25%Risk of medication errors and hepatotoxicity. Dosing errors could lead to accidental death and overdose.

    Risk of acute liver failure, liver transplant, or death
    Known hypersensitivity to acetaminophen or excipients

    Severe hepatic impairment or active liver disease

References

    1. Alvogen (personal communication). April 7, May 17, October 11, December 20, 2018; February 7, May 2 and 21, June 5, July 2 and 22, December 16, 2019; January 20 and 30, March 6 and 13, May 4, July 14, September 11, and October 14, 2020.
    2. Amphastar (personal communications). October 4, 2016; January 9, August 29, and September 11, 2017; May 14, July 9, and August 1, 2018; April 30, 2019; and January 29, 2020.
    3. Athenex (personal communications). February 20, March 8 and 12, April 4, May 14, July 3, August 1, September 12, December 27, 2018; February 7, April 30, June 26, August 27, November 5, 2019; February 19, March 5, April 20, May 28, and October 12, 2020.
    4. Baxter (personal communication). July 14 and 21, and October 6, 2020.
    5. BD Rx (personal communications). November 11, 2015; and February 4, 2016.
    6. Fresenius Kabi (personal communications). February 2, 11, 18, and 24, March 11, 18, and 31, May 6 and 20, June 30, July 6, August 6, September 10, October 8, November 4, December 11, 2015; January 20, February 5 and 18, March 7, May 13 and 23, June 8 and 30, July 29, September 6, October 4 and 27, 2016; January 28, February 20, March 21, June 2 and 20, July 7 and 28, August 24, September 21, November 10, 17, and 30, December 15, 2017; January 12, February 5 and 15, March 2, 9, 20, and 23, April 6 and 27, May 3, 10, and 25, July 5 and 27, August 29, September 6 and 28, October 5, November 2, December 14, 2018; January 3 and 11, February 1, March 21 and 29, April 5 and 26, May 3, 11, 17, and 30, June 7 and 24, July 5, 12, and 16, August 2, 16, and 30, September 16 and 27, October 18, November 1, 8, and 22, December 13 and 20, 2019; January 17, 21, and 24, March 6, 13, and 20, April 17, May 1, July 17 and 24, and October 9 and 23, 2020.
    7. Pfizer (personal communications and website). February 10 and 24, March 2, 13, and 20, April 1 and 7, May 11 and 22, July 2 and 27, September 15, October 12, November 12, December 11, 2015; January 26, February 5, 22, and 25, March 7, April 28, May 20, June 16 and 23, July 7, August 2, September 6, October 4, November 6, 2016; January 30, February 23, March 24, June 2, 5, and 23, July 7, 14, and 28, August 28, September 29, October 11, November 15, 20, and 28, December 1 and 18, 2017; January 12, February 2, 16 and 23, March 5, 9, and 23, April 2, May 1, 11, and 25, June 22, July 10 and 25, August 30, October 4, November 6, December 18, 2018; January 17, February 7, March 25, April 1 and 30, May 5, 21, and 31, June 24, July 9, 12, and 23, August 2, 20, and 30, September 17 and 27, October 21, November 4 and 25, December 13 and 20, 2019; January 22, March 6 and 13, April 17, 1, July 20 and 31, and October 9 and 23, 2020.
    8. Sagent (personal communications). February 9, 19, and 26, March 12, 20, and 27, April 2, May 7 and 21, July 2 and 30, September 10, October 8, November 5, December 10, 2015; January 21, February 4 and 18, March 7, April 28, May 19 and 26, June 16, July 7 and 29, September 6, October 4, November 3, 2016; January 27, February 23, March 23, June 1 and 22, July 7 and 28, August 24, September 28, November 9, 16, 22, and 30, December 14, 2017; January 11, February 1 and 22, March 1, 22, and 29, May 3, 10, and 24, June 21, July 5 and 26, August 30, October 4, November 1, December 13, 2018; January 3 and 17, February 7, March 21 and 28, April 4 and 25, May 16 and 30, July 5 and 12, August 1 and 30, September 12 and 27, October 17, November 6 and 21, December 12, 2019; January 16, March 6 and 13, April 16 and 30, July 16 and 30, and October 8 and 22, 2020.
    9. Hikma (personal communications). January 29, February 18, March 11, April 2, and May 6, June 24, July 29, September 1, 2015; January 27, March 29, 2016; May 2, 10, and 23, June 20, July 3 and 25, August 29, September 5, October 3 and 31, 2018; January 16 and 30, March 20 and 27, April 3 and 24, May 2, 16, and 29, June 19, July 3, 10, 24, and 31, August 21, September 18 and 25, October 16, November 6 and 20, December 11 and 18, 2019; January 22, March 4 and 12, April 15 and 29, July 15 and 29, and October 7 and 21, 2020.
    10. Fosun Pharma (personal communications). June 10, 2019; and July 31, 2020.
    11. Ben Venue (personal communications). August 5, 2014.
    12. Virtus. (personal communications). February 20, April 4, May 15, July 10, October 4, 2018, February 7, and May 1, 2019.
    13. Wockhardt (personal communications). December 9, 2013.
    14. Egalet Corporation (personal communications). April 1, 2015.
    15. Hospira. Ketorolac tromethamine injection solution [product information]. Lake Forest, IL: Hospira 2014.
    16. Anon, editor. Drugdex System. Micromedex 2.0 [internet database]. Greenwood Village, CO: Truven Health Analytics; 2015.
    17. Wickersham RM, Novak KK, managing eds., editors. Drug Facts and Comparisons (Facts & Comparisons eAnswers). St. Louis, MO: Wolters Kluwer Health, Inc.; 2015.
    18. Cumberland Pharmaceuticals Inc. Caldolor (ibuprofen) Injection, for intravenous use [product information]. Nashville, TN: Cumberland Pharmaceuticals Inc.; 2014.
    19. Hospira. Dyloject (diclofenac sodium) Injection [product information]. Lake Forest, IL: Hospira 2014.
    20. Cadence Pharmaceuticals. Ofirmev (acetaminophen) Injection [product information]. San Diego, CA: Cadence Pharmaceuticals, Inc.; 2010.
    21. Regency Therapeutics. Sprix (ketorolac tromethamine) nasal spray [product information]. Shirley, NY: American Regent 2014.

Updated

Updated October 26, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. Created August 6, 2015 by Jane Chandramouli, PharmD, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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