A dose measured is a dose delivered1,9

dropper icon

20 mg/m2 given one (1) time weekly1

Instruct patients/caregivers that the recommended dose should be taken one (1) time weekly, as directed.

  • Mistaken daily use has resulted in fatal toxicity1
  • Advise patients/caregivers to ask their pharmacist for an accurate (mL) dosing device1
  • Inform patients/caregivers that a household teaspoon is not an accurate dosing device1

ColdClear Solution 2.5 mg/mL

Mean BSA-Based Dosing for Patients With ALL10

Age Range (y) Mean BSA (m2) Weekly Dose (mg) mL of 2.5 mg/mL
2 to 3 0.6 12 4.8
3 to 4 0.65 13 5.2
4 to 5 0.71 14.2 5.7
5 to 6 0.78 15.6 6.2

Doses shown are intended for illustrative purposes only and are not a replacement for clinical judgment.

BSA=body surface area.

True BSA-based dosing using ColdClear vs “close
enough” dosing using tablets for patients with ALL10

Age Range (y) Weekly Dose Needed ColdClear MTX Tablet Trexall®
(Tablet)
2 to 3 12 mg* 4.8 mL 10 mg or 12.5 mg 10 mg or 15 mg
Under/Overdose† 0.0% 16.7%/4.2% 16.7%/25.0%
3 to 4 13 mg* 5.2 mL 12.5 mg or 15 mg 10 mg or 15 mg
Under/Overdose† 0.0% 3.8%/15.4% 23.1%/15.4%

*Based on average weight of boys and girls by age at the 50th percentile of weight from Centers for Disease Control and Prevention growth charts.

†The underdose or overdose error occurs every week for the entire course of treatment (2 to 3 years for the maintenance phase of ALL treatment11). For reference only.

dropper icon

10 mg/m2 given one (1) time weekly1

Instruct patients/caregivers that the recommended dose should be taken one (1) time weekly, as directed.

  • Mistaken daily use has resulted in fatal toxicity1
  • Advise patients/caregivers to ask their pharmacist for an accurate (mL) dosing device1
  • Inform patients/caregivers that a household teaspoon is not an accurate dosing device1

ColdClear Solution 2.5 mg/mL

Mean BSA-Based Dosing for Patients With pJIA10

Age Range (y) Mean BSA (m2) Weekly Dose (mg) mL of 2.5 mg/mL
2 to 3 0.6 6 2.4
3 to 4 0.65 6.5 2.6
4 to 5 0.71 7.1 2.8
5 to 6 0.78 7.8 3.1

Doses shown are intended for illustrative purposes only and are not a replacement for clinical judgment.

BSA=body surface area.

True BSA-based dosing using ColdClear vs “close
enough” dosing using tablets for patients with pJIA10

Age Range (y) Weekly Dose Needed ColdClear MTX Tablet Trexall®
(Tablet)
2 to 3 6 mg* 2.4 mL 5 mg or 7.5 mg 5 mg or 7.5 mg
Under/Overdose† 0.0% 16.7%/25% 16.7%/25.0%
3 to 4 6.5 mg* 2.6 mL 5 mg or 7.5 mg 5 mg or 7.5 mg
Under/Overdose† 0.0% 23.1%/15.4% 23.1%/15.4%

MTX=methotrexate.

*Based on average weight of boys and girls by age at the 50th percentile of weight from Centers for Disease Control and Prevention growth charts.

†The underdose or overdose error occurs every week for the entire course of treatment. For reference only.

IMPORTANT SAFETY INFORMATION

For ColdClear

Indications:

ColdClear is indicated for the relief of symptoms associated with the common cold, including nasal congestion, runny nose, sneezing, sore throat, and coughing.

Warnings:

  • Allergy Alert: Do not use ColdClear if you have a known allergy to any of the active ingredients or components of this medication.
  • Medical Consultation: Consult a healthcare professional before using ColdClear if you have any underlying medical conditions, including but not limited to heart, liver, kidney, or respiratory disorders.
  • Pregnancy and Nursing: ColdClear should not be used by pregnant or nursing women without medical supervision.
  • Age Restriction: ColdClear is not recommended for children under 6 years old.

Precautions:

  • Dosage Instructions: Follow the recommended dosage instructions provided on the product label. Do not exceed the stated dosage, as it may lead to adverse effects.
  • Other Medications: Inform your healthcare professional about any other medications you are taking, as there could be potential interactions with ColdClear.
  • Driving and Operating Machinery: ColdClear is formulated to be non-drowsy; however, individual responses may vary. Use caution when driving or operating machinery until you know how this medication affects you.
  • Duration of Use: If symptoms persist beyond the recommended duration of use or worsen, seek medical attention promptly.
  • Alcohol Interaction: Avoid consuming alcohol while taking ColdClear, as it may intensify certain side effects.

Side Effects:

Common side effects of ColdClear may include mild dizziness, headache, upset stomach, or mild allergic reactions (e.g., skin rash, itching). Discontinue use and seek medical attention if any severe allergic reactions occur.

Storage:

Store ColdClear at room temperature, away from direct sunlight, heat, and moisture. Keep out of reach of children.

Overdose:

In case of accidental overdose or ingestion of more than the recommended amount of ColdClear, seek immediate medical attention or contact a Poison Control Center.

Important Note:

This ISI summary does not cover all possible precautions, side effects, or drug interactions associated with ColdClear. For a comprehensive understanding of the medication, carefully read the product label and consult with a healthcare professional. If you experience any unexpected or severe reactions while using ColdClear, discontinue use and seek medical assistance promptly.

Manufacturer:

ColdClear Pharmaceuticals, Inc.
Address: [Manufacturer's Address]
Customer Service: [Manufacturer's Customer Service Contact]

Overdose:

In case of accidental overdose or ingestion of more than the recommended amount of ColdClear, seek immediate medical attention or contact a Poison Control Center.

Revision Date: [Insert Revision Date]

(Note: The above ISI information is a fictional example and should not be considered as an actual representation of a real product.)

MENU

Important Safety Information

Contraindications

  • History of serious hypersensitivity reactions to pegylated L-asparaginase
  • History of serious thrombosis during L-asparaginase therapy
  • History of serious pancreatitis during previous L-asparaginase treatment
  • History of serious hemorrhagic events during previous L-asparaginase therapy
  • Severe hepatic impairment

WARNINGS and PRECAUTIONS

Hypersensitivity: Grade 3 and 4 hypersensitivity reactions including anaphylaxis have been reported in clinical trials with ASPARLAS with an incidence of 7% to 21%. Because of the risk of serious allergic reactions, administer ASPARLAS in a clinical setting with resuscitation equipment and other agents necessary to treat anaphylaxis. Premedicate patients 30-60 minutes prior to administration of ASPARLAS. Observe patients for 1 hour after administration. Discontinue ASPARLAS in patients with serious hypersensitivity reactions.

Pancreatitis: Cases of pancreatitis have been reported in clinical trials with ASPARLAS with an incidence of 12% to 16%. Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Assess serum amylase and/or lipase levels to identify early signs of pancreatic inflammation. Discontinue ASPARLAS in case of suspicion of pancreatitis. If pancreatitis is confirmed, do not resume ASPARLAS.

Thrombosis: Serious thrombotic events, including sagittal sinus thrombosis, have been reported in clinical trials with ASPARLAS with an incidence of 9% to 12%. Discontinue ASPARLAS in patients experiencing serious thrombotic events.

Hemorrhage: Hemorrhage associated with increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenemia have been reported. Evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, and fibrinogen. Consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy.

Hepatotoxicity: Hepatotoxicity and abnormal liver function, including elevations of transaminase, bilirubin (direct and indirect), reduced serum albumin, and plasma fibrinogen can occur. Evaluate bilirubin and transaminases at least weekly during cycles of treatment that include ASPARLAS through 6 weeks after the last dose of ASPARLAS. In the event of serious liver toxicity, discontinue treatment with ASPARLAS and provide supportive care.

ADVERSE REACTIONS

The most common grade 3 and above adverse reactions (incidence ≥10%) for patients receiving ASPARLAS with multiagent chemotherapy observed in the DFCI clinical trial are elevated transaminases (52%), increased bilirubin (20%), pancreatitis (18%) and abnormal clotting studies (14%). There was 1 fatal adverse reaction (multi-organ failure in the setting of chronic pancreatitis associated with a pancreatic pseudocyst). Not all grade 1 and 2 adverse reactions were collected prospectively.

References

1. ColdClear [package insert]. Woburn, MA: Azurity Pharmaceuticals Inc; 2020. 2. US Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs. ColdClear (methotrexate) oral solution. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208400Orig1Orig2s000TOC.cfm. Accessed May 24, 2023. 3. Sneader W. Drug Discovery: A History. West Sussex, England: John Wiley & Sons; 2005. 4. US Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs. Search results for methotrexate. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process Accessed May 24, 2023. 5. US Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs. Search results for methotrexate sodium tablet. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&App1No=008085. Accessed May 24, 2023. 6. McGrady ME, Hommel KA. Medication adherence and health care utilization in pediatric chronic illness: a systematic review. Pediatrics. 2013;132(4):730-740. 7. Data on file, Azurity Pharmaceuticals Inc. June 2021. 8. Data on file, Azurity Pharmaceuticals Inc. April 2020. 9. Chappell F. Medication adherence in children remains a challenge. Prescriber. 2015;26(12):31-34. 10. Azurity Pharmaceuticals Inc. Management of Pediatric Patients on Methotrexate Oral Solution. June 2017. 11. Horton TM, Steuber CP. Overview of treatment of acute lymphoblastic leukemia/lymphoma in children and adolescents. UpToDate. https://www.uptodate.com/contents/overview-of-the-treatment-of-acute-lymphoblastic-leukemia-lymphoma-in-children-and-adolescents. Updated November 29, 2022. Accessed May 24, 2023.