Sodium thiosulfate

Dosage Forms & Strengths

injection solution

• 100mg/mL (10%)
• 250mg/mL (25%)

Cyanide Poisoning

12.5 g IV (infuse over 10-20 minutes)

Cisplatin Extravasation

2 mL 1/6 molar solution through IV cannula for every 100 mg cisplatin; remove needle, then inject 0.1 mL injections clockwise around extravasation area up to 1 mL; repeat several times within the 3-4 hr of extravasation incident

Cisplatin Nephrotoxicity

4 g/m² IV bolus followed by 12 g/m² IV infusion over 6 hr

Preparation of 1/6 Molar Solution

4 mL of 10% solution + 6 mL sterile water for injection

1.6 mL of 25% solution + 8.4 mL sterile water for injection

Orphan Designations

Calciphylaxis: 25 g IV 3 times per week following dialysis for 6 weeks to 9 months; other protocols exist

Mechlorethamine extravasation: 2 mL 10% solution through IV cannula for every 2 mg mechlorethamine extravasated; remove needle, then inject 10 mL of 1/6 molar solution SC

Sulfur mustard poisoning

Dermatomyositis

Orphan sponsor

• Hope Pharmaceuticals; 16416 N. 92nd Street, Suite 125; Scottsdale, AZ 85260

Administration

Monitor for thiocyanate toxicity

Dosage Forms & Strengths

injection solution

• 100mg/mL (10%)
• 250mg/mL (25%)

Cyanide Poisoning

7 g/m² IV (maximum 12.5 g), infuse over at least 10 minutes 

Platinum-Induced Ototoxicity (Orphan)

Prevention of platinum-induced ototoxicity in pediatric patients

Orphan sponsor

• Adherex Technologies, Inc; 501 Eastowne Dr Suite 140; Chapel Hill, NC 27514
• Hope Pharmaceuticals; 16416 N. 92nd Street Suite 125; Scottsdale, AZ 85260

Warnings/Precautions

Sensitivity Reactions

Possible irritation or sensitivity; if occurs, discontinue therapy.a b

General Precautions

When used in fixed combination with salicylic acid, consider the cautions, precautions, and contraindications associated with salicylic acid.a

Specific Populations

Category C.d

Manufacturer states safety and efficacy not established in children <12 years of age.c

Elimination

Elimination Route

Systemically absorbed drug is excreted in urine (29% as unchanged drug).e

Half-life

Systemically absorbed drug: 80 minutes.e

• Active against Malassezia furfur (Pityrosporum ovale).a

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Feeling confused.
• Any unexplained bruising or bleeding.

Cyanide poisoning: IV: Note: Administer in conjunction with sodium nitrite. Administer sodium nitrite first, followed immediately by the administration of sodium thiosulfate: 12.5 g (50 mL of a 25% solution); may repeat at one-half the original dose if symptoms of cyanide toxicity return

Note: Monitor the patient for 24 to 48 hours; if symptoms return, repeat both sodium nitrite and sodium thiosulfate at one-half the original doses.

Calciphylaxis (off-label use): IV: Note: Optimal dose is not established.

Dialysis patients: 25 g administered 3 times per week during the last hour of or after the hemodialysis session. Therapy should continue until there is complete resolution of symptoms (Ackermann 2007; Auriemma 2011; Cicone 2004; Nigwekar 2013; Subramaniam 2008).

Patients not on dialysis (normal renal function or mildly reduced GFR): 25 g administered 3 times per week (Baker 2007; Hackett 2011).

Extravasation management (off-label use):

Mechlorethamine: SubQ (off-label route): Inject 2 mL of a 1/6 M (~4%) sodium thiosulfate solution (into the extravasation site) for each mg of mechlorethamine suspected to have extravasated (Pérez Fidalgo 2012; Polovich 2009)

Cisplatin, concentrated: Inject 2 mL of a 1/6 M (~4%) sodium thiosulfate solution into existing IV line for each 100 mg of cisplatin extravasated; consider also injecting 1 mL of a 1/6 M (~4%) sodium thiosulfate solution as 0.1 mL subcutaneous injections (clockwise) into the area around the extravasation, may repeat subcutaneous injections several times over the next 3-4 hours (Ener 2004)

Bendamustine: SubQ: Bendamustine extravasation may be managed with 1/6 M (~4%) sodium thiosulfate solution in the same manner as mechlorethamine extravasation (Schulmeister 2011)

Management of delayed calcium extravasation (calcinosis cutis) (off-label use): IV: 12.5 g over 30 minutes; may increase gradually to 25 g 3 times per week; monitor for non-anion gap acidosis, hypocalcemia, severe nausea (Reynolds 2014). Additional data may be necessary to further define the role of sodium thiosulfate for this condition.

No dosage adjustment provided in the manufacturer’s labeling (has not been studied).

Calciphylaxis (off-label use): May dilute dose in 100 mL of NS (Nigwekar 2013)

Extravasation management (off-label use/route): To prepare a 1/6 M solution for SubQ administration (off-label route), add 4 mL of a 10% sodium thiosulfate solution to 6 mL SWFI or 1.6 mL of a 25% sodium thiosulfate solution to 8.4 mL SWFI (Polovich 2009).

Cyanide poisoning: Monitor for at least 24-48 hours after administration; blood pressure and heart rate during and after infusion; hemoglobin/hematocrit; co-oximetry; serum lactate levels; venous-arterial PO2 gradient; serum methemoglobin and oxyhemoglobin. Pretreatment cyanide levels may be useful diagnostically.

Extravasation management: Monitor and document extravasation site for pain, blister formation, skin sloughing, arm/hand swelling/stiffness; monitor for fever, chills, or worsening pain

When used in the management of delayed calcium extravasation (calcinosis cutis), monitor for non-anion gap acidosis, hypocalcemia, severe nausea (Reynolds 2014).

Teratogenic effects were not observed in animal reproduction studies of sodium thiosulfate. In general, medications used as antidotes should take into consideration the health and prognosis of the mother; antidotes should be administered to pregnant women if there is a clear indication for use and should not be withheld because of fears of teratogenicity (Bailey 2003).