Fragmin

(Dalteparin Sodium)

Check Drug InteractionsCheck known drug interactions.

Fragmin Prescribing Information

Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

•
Use of indwelling epidural catheters
•
Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants.
•
A history of traumatic or repeated epidural or spinal punctures
•
A history of spinal deformity or spinal surgery
•
Optimal timing between the administration of FRAGMIN and neuraxial procedures is not known

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis

[see

5.1 Risk of Hemorrhage including Spinal/Epidural Hematomas

Spinal or epidural hemorrhage and subsequent hematomas can occur with the associated use of low molecular weight heparins or heparinoids and neuraxial (spinal/epidural) anesthesia or spinal puncture. The risk of these events is higher with the use of post-operative indwelling epidural catheters, with the concomitant use of additional drugs affecting hemostasis such as NSAIDs, with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity

[see Boxed Warning, Adverse Reactions (6.2), and Drug Interactions (7)]

To reduce the potential risk of bleeding associated with the concurrent use of FRAGMIN and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of FRAGMIN

[see Clinical Pharmacology (12.3)].

Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of FRAGMIN is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known. No additional hemostasis-altering medications should be administered due to the additive effects.

Patients on preoperative FRAGMIN thromboprophylaxis can be assumed to have altered coagulation. The first postoperative FRAGMIN thromboprophylaxis dose (2,500 units) should be administered 6 hours to 8 hours postoperatively. The second postoperative dose (2,500 units or 5,000 units) should occur no sooner than 24 hours after the first dose. Placement or removal of a catheter should be delayed for at least 12 hours after administration of 2,500 units once daily of FRAGMIN, at least 15 hours after the administration of 5,000 units once daily of FRAGMIN, and at least 24 hours after the administration of higher doses (200 units/kg once daily, 120 units/kg twice daily) of FRAGMIN. Anti-Xa levels are still detectable at these time points, and these delays are not a guarantee that neuraxial hematoma will be avoided.

Although a specific recommendation for timing of a subsequent FRAGMIN dose after catheter removal cannot be made, consider delaying this next dose for at least 4 hours, based on a benefit-risk assessment considering both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors. For patients with creatinine clearance <30 mL/minute, additional considerations are necessary because elimination of FRAGMIN may be more prolonged; consider doubling the timing of removal of a catheter, at least 24 hours for the lower prescribed dose of FRAGMIN (2,500 units or 5,000 units once daily) and at least 48 hours for the higher dose (200 units/kg once daily, 120 units/kg twice daily)

[see Clinical Pharmacology (12.3)].

Should the physician decide to administer anticoagulation in the context of epidural or spinal anesthesia/analgesia or lumbar puncture, frequent monitoring must be exercised to detect any signs and symptoms of neurological impairment such as midline back pain, sensory and motor deficits (numbness or weakness in lower limbs), bowel and/or bladder dysfunction. Instruct patients to report immediately if they experience any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae.

Use FRAGMIN with extreme caution in patients who have an increased risk of hemorrhage, such as those with severe uncontrolled hypertension, bacterial endocarditis, congenital or acquired bleeding disorders, active ulceration and angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spinal or ophthalmological surgery. FRAGMIN may enhance the risk of bleeding in patients with thrombocytopenia or platelet defects; severe liver or kidney insufficiency, hypertensive or diabetic retinopathy, and recent gastrointestinal bleeding. Bleeding can occur at any site during therapy with FRAGMIN.

and

7 DRUG INTERACTIONS

The use of FRAGMIN in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents may increase the risk of bleeding

[see Warnings and Precautions (5)]

The use of FRAGMIN in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents may increase the risk of bleeding

]

Indications and Usage, Treatment of Symptomatic Venous Thromboembolism (VTE) in Pediatric Patients (

1.4 Treatment of Symptomatic Venous Thromboembolism (VTE) in Pediatric Patients

FRAGMIN is indicated for the treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in pediatric patients

from birth (gestational age at least 35 weeks)

)

10/2024

Dosage and Administration, Treatment of Symptomatic Venous Thromboembolism (VTE) in Pediatric Patients (

2.4 Treatment of Symptomatic Venous Thromboembolism (VTE) in Pediatric Patients

The recommended starting dose according to pediatric age is provided in Table 5.

2 Years to less than 8 Years8 Years to less than 17 Years


Table 5
Starting Doses for Pediatric Patients with Symptomatic VTE
Age Group	Starting Dose
Birth (gestational age at least 35 weeks) to less than 2 Years	150 units/kg twice daily

125 units/kg twice daily

100 units/kg twice daily

After initiation of FRAGMIN, measure anti-Xa level prior to the 4^thdose. Samples for anti-Xa level should be drawn 4 hours after administration of FRAGMIN. Adjust doses in increments of 25 units/kg to achieve target anti-Xa level between 0.5 units/mL and 1 unit/mL. Individualize the maintenance dose of FRAGMIN based on the dose that achieves target anti-Xa level collected 4 hours after administration of FRAGMIN

Monitor anti-Xa level periodically in pediatric patients to maintain anti-Xa level between 0.5 units/mL and 1 unit/mL

[see Clinical Pharmacology (12.3)and Clinical Studies (14.5)]

The 3.8 mL multiple-dose vials of FRAGMIN contain 14 mg/mL of benzyl alcohol

[see Warnings and Precautions (5.3)]

Whenever possible, administer benzyl alcohol-free formulations (prefilled syringes) in pediatric patients

[see Warnings and Precautions (5.3)and Use in Specific Populations (8.4)]

The 10,000 units/4 mL (2,500 units/mL) single-dose vials are preservative-free. For treatment of neonates, use this vial presentation.

)

10/2024

Dosage and Administration, Dose Reductions for Thrombocytopenia in Adult Patients with Cancer and in Pediatric Patients with

Symptomatic VTE (

2.5 Dose Reductions for Thrombocytopenia in Adult Patients with Cancer and in Pediatric Patients with Symptomatic VTE

Dose reductions recommended in patients receiving FRAGMIN who experience thrombocytopenia are presented below in Table 6.

Table 6

Platelet Count less than or equal to 50,000/mm³

Platelet Count greater than 50,000/mm³up to 100,000/mm³

Adults

Discontinue FRAGMIN until platelet count recovers to above 50,000/mm³.

Reduce the daily dose of FRAGMIN by 2,500 units until the platelet count recovers to greater or equal to 100,000/mm³.

Children

from birth (gestational age at least 35 weeks)

to less than 17 Years

Discontinue FRAGMIN until platelet count recovers to above 50,000/mm³.

Reduce the daily dose of FRAGMIN by 50% until the platelet count recovers to greater or equal to 100,000/mm³.

)

10/2024

FRAGMIN is a low molecular weight heparin (LMWH) indicated for

•Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (
1.1 Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction
FRAGMIN Injection is indicated for the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy
[see Clinical Studies (14.1)]
.
)
•Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness (
1.2 Prophylaxis of Deep Vein Thrombosis
FRAGMIN is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
- •In patients undergoing hip replacement surgery
  [see Clinical Studies (14.2)]
  ;
- •In patients undergoing abdominal surgery who are at risk for thromboembolic complications
  [see Clinical Studies (14.3)]
  ;
- •In medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness
  [see Clinical Studies (14.4)]
  .
)
•Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months (
1.3 Extended Treatment of Symptomatic Venous Thromboembolism (VTE) in Adult Patients with Cancer
FRAGMIN is indicated for the extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or PE), to reduce the recurrence of VTE in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months
[see Clinical Studies (14.5)]
.
)
•Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients from birth (gestational age at least 35 weeks) (
1.4 Treatment of Symptomatic Venous Thromboembolism (VTE) in Pediatric Patients
FRAGMIN is indicated for the treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in pediatric patients
from birth (gestational age at least 35 weeks)
.
)
•
Limitations of Use

FRAGMIN is not indicated for the acute treatment of VTE (
1.5 Limitations of Use
FRAGMIN is not indicated for the acute treatment of VTE.
)

Indication

Dosing Regimen

Unstable angina and non-Q-wave MI

120 units/kg subcutaneous every 12 hours (with aspirin) (

2.1 Recommended Dosage for Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction

In patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of FRAGMIN Injection is 120 units/kg of body weight, but not more than 10,000 units, subcutaneously every 12 hours with concurrent oral aspirin (75 mg to 165 mg once daily) therapy. Treatment should be continued until the patient is clinically stabilized. The usual duration of administration is 5 days to 8 days. Concurrent aspirin therapy is recommended except when contraindicated.

Table 1 lists the volume of FRAGMIN in mL (based on the 3.8 mL multiple-dose vial 25,000 units/mL) and quantity of FRAGMIN in units, to be administered for a range of patient weights.

Table 1
Quantity and Volume of FRAGMIN to be Administered by Patient Weight
Patient weight (kg)	<50 kg	50 kg to 59 kg	60 kg to 69 kg	70 kg to 79 kg	80 kg to 89 kg	≥90 kg
Quantity of FRAGMIN (units)	5,500 units	6,500 units	7,500 units	9,000 units	10,000 units	10,000 units
Volume of FRAGMIN (mL) 95,000 units / 3.8 mL	0.22 mL	0.26 mL	0.3 mL	0.36 mL	0.4 mL	0.4 mL

)

DVT prophylaxis in abdominal surgery

2,500 units subcutaneous once daily or 5,000 units subcutaneous once daily or 2,500 units subcutaneous followed by 2,500 units subcutaneous 12 hours later and then 5,000 units subcutaneous once daily (

2.2 Prophylaxis of Deep Vein Thrombosis

Prophylaxis of VTE Following Hip Replacement Surgery

: Table 2 presents the dosing options for patients undergoing hip replacement surgery. The usual duration of administration is 5 days to 10 days after surgery; up to 14 days of treatment with FRAGMIN have been well tolerated in clinical trials.

Table 2
Dosing Options for Patients Undergoing Hip Replacement Surgery
Timing of First Dose of FRAGMIN	Dose of FRAGMIN to be Given Subcutaneously
Timing of First Dose of FRAGMIN	10 Hours to 14 Hours Before Surgery	Within 2 Hours Before Surgery	4 Hours to 8 Hours After SurgeryOr later, if hemostasis has not been achieved.	Postoperative PeriodUp to 14 days of treatment was well tolerated in controlled clinical trials, where the usual duration of treatment was 5 days to 10 days postoperatively.
Postoperative Start	---	---	2,500 unitsAllow a minimum of 6 hours between this dose and the dose to be given on Postoperative Day 1. Adjust the timing of the dose on Postoperative Day 1 accordingly.	5,000 units once daily
Preoperative Start - Day of Surgery	---	2,500 units	2,500 units	5,000 units once daily
Preoperative Start - Evening Before SurgeryAllow approximately 24 hours between doses.	5,000 units	---	5,000 units	5,000 units once daily

Abdominal Surgery:

In patients undergoing abdominal surgery with a risk of thromboembolic complications, the recommended dose of FRAGMIN is 2,500 units administered by subcutaneous injection once daily, starting 1 hour to 2 hours prior to surgery and repeated once daily postoperatively. The usual duration of administration is 5 days to 10 days.

In patients undergoing abdominal surgery associated with a high risk of thromboembolic complications, such as malignant disorder, the recommended dose of FRAGMIN is 5,000 units subcutaneously the evening before surgery, then once daily postoperatively. The usual duration of administration is 5 days to 10 days. Alternatively, in patients with malignancy, 2,500 units of FRAGMIN can be administered subcutaneously 1 hour to 2 hours before surgery followed by 2,500 units subcutaneously 12 hours later, and then 5,000 units once daily postoperatively. The usual duration of administration is 5 days to 10 days.

Medical Patients During Acute Illness:

In medical patients with severely restricted mobility during acute illness, the recommended dose of FRAGMIN is 5,000 units administered by subcutaneous injection once daily. In clinical trials, the usual duration of administration was 12 days to 14 days.

)

DVT prophylaxis in hip replacement surgery

Postoperative start –

2,500 units subcutaneous 4 hours to 8 hours after surgery, then 5,000 units subcutaneous once daily, or

Preoperative start – day of surgery

2,500 units subcutaneous 2 hours before surgery followed by 2,500 units subcutaneous 4 hours to 8 hours after surgery, then 5,000 units subcutaneous once daily (

2.2 Prophylaxis of Deep Vein Thrombosis

Prophylaxis of VTE Following Hip Replacement Surgery

Table 2
Dosing Options for Patients Undergoing Hip Replacement Surgery
Timing of First Dose of FRAGMIN	Dose of FRAGMIN to be Given Subcutaneously
Timing of First Dose of FRAGMIN	10 Hours to 14 Hours Before Surgery	Within 2 Hours Before Surgery	4 Hours to 8 Hours After SurgeryOr later, if hemostasis has not been achieved.	Postoperative PeriodUp to 14 days of treatment was well tolerated in controlled clinical trials, where the usual duration of treatment was 5 days to 10 days postoperatively.
Postoperative Start	---	---	2,500 unitsAllow a minimum of 6 hours between this dose and the dose to be given on Postoperative Day 1. Adjust the timing of the dose on Postoperative Day 1 accordingly.	5,000 units once daily
Preoperative Start - Day of Surgery	---	2,500 units	2,500 units	5,000 units once daily
Preoperative Start - Evening Before SurgeryAllow approximately 24 hours between doses.	5,000 units	---	5,000 units	5,000 units once daily

Abdominal Surgery:

Medical Patients During Acute Illness:

)

Preoperative start – Evening Before Surgery

5,000 units subcutaneous followed by 5,000 units subcutaneous 4 hours to 8 hours after surgery (

2.2 Prophylaxis of Deep Vein Thrombosis

Prophylaxis of VTE Following Hip Replacement Surgery

Table 2
Dosing Options for Patients Undergoing Hip Replacement Surgery
Timing of First Dose of FRAGMIN	Dose of FRAGMIN to be Given Subcutaneously
Timing of First Dose of FRAGMIN	10 Hours to 14 Hours Before Surgery	Within 2 Hours Before Surgery	4 Hours to 8 Hours After SurgeryOr later, if hemostasis has not been achieved.	Postoperative PeriodUp to 14 days of treatment was well tolerated in controlled clinical trials, where the usual duration of treatment was 5 days to 10 days postoperatively.
Postoperative Start	---	---	2,500 unitsAllow a minimum of 6 hours between this dose and the dose to be given on Postoperative Day 1. Adjust the timing of the dose on Postoperative Day 1 accordingly.	5,000 units once daily
Preoperative Start - Day of Surgery	---	2,500 units	2,500 units	5,000 units once daily
Preoperative Start - Evening Before SurgeryAllow approximately 24 hours between doses.	5,000 units	---	5,000 units	5,000 units once daily

Abdominal Surgery:

Medical Patients During Acute Illness:

)

DVT prophylaxis in medical patients

5,000 units subcutaneous once daily (

2.2 Prophylaxis of Deep Vein Thrombosis

Prophylaxis of VTE Following Hip Replacement Surgery

Table 2
Dosing Options for Patients Undergoing Hip Replacement Surgery
Timing of First Dose of FRAGMIN	Dose of FRAGMIN to be Given Subcutaneously
Timing of First Dose of FRAGMIN	10 Hours to 14 Hours Before Surgery	Within 2 Hours Before Surgery	4 Hours to 8 Hours After SurgeryOr later, if hemostasis has not been achieved.	Postoperative PeriodUp to 14 days of treatment was well tolerated in controlled clinical trials, where the usual duration of treatment was 5 days to 10 days postoperatively.
Postoperative Start	---	---	2,500 unitsAllow a minimum of 6 hours between this dose and the dose to be given on Postoperative Day 1. Adjust the timing of the dose on Postoperative Day 1 accordingly.	5,000 units once daily
Preoperative Start - Day of Surgery	---	2,500 units	2,500 units	5,000 units once daily
Preoperative Start - Evening Before SurgeryAllow approximately 24 hours between doses.	5,000 units	---	5,000 units	5,000 units once daily

Abdominal Surgery:

Medical Patients During Acute Illness:

)

Extended treatment of VTE in adult patients with cancer

Month 1: 200 units/kg subcutaneous once daily (

2.3 Extended Treatment of Symptomatic Venous Thromboembolism (VTE) in Adult Patients with Cancer

In adult patients with cancer and symptomatic VTE, the recommended dosing of FRAGMIN is as follows: for the first 30 days of treatment administer FRAGMIN 200 units/kg total body weight subcutaneously once daily. The total daily dose should not exceed 18,000 units. Table 3 lists the dose of FRAGMIN to be administered once daily during the first month for a range of patient weights.

Month 1

Table 3
Dose of FRAGMIN to be Administered Subcutaneously by Patient Weight during the First Month
Body Weight (kg)	FRAGMIN Dose (units) (prefilled syringe) once daily
≤56 kg	10,000 units
57 kg to 68 kg	12,500 units
69 kg to 82 kg	15,000 units
83 kg to 98 kg	18,000 units
≥99 kg	18,000 units

Months 2 to 6

Administer FRAGMIN at a dose of approximately 150 units/kg, subcutaneously once daily during Months 2 through 6. The total daily dose should not exceed 18,000 units. Table 4 lists the dose of FRAGMIN to be administered once daily for a range of patient weights during months 2 to 6.

Table 4
Dose of FRAGMIN to be Administered Subcutaneously by Patient Weight during Months 2 to 6
Body Weight (kg)	FRAGMIN Dose (units) (prefilled syringe) once daily
≤56 kg	7,500 units
57 kg to 68 kg	10,000 units
69 kg to 82 kg	12,500 units
83 kg to 98 kg	15,000 units
≥99 kg	18,000 units

Safety and efficacy beyond six months have not been evaluated in patients with cancer and acute symptomatic VTE

[see Warnings and Precaution (5)and Adverse Reactions (6.1)]

)

Months 2 to 6: 150 units/kg subcutaneous once daily (

2.3 Extended Treatment of Symptomatic Venous Thromboembolism (VTE) in Adult Patients with Cancer

Month 1

Table 3
Dose of FRAGMIN to be Administered Subcutaneously by Patient Weight during the First Month
Body Weight (kg)	FRAGMIN Dose (units) (prefilled syringe) once daily
≤56 kg	10,000 units
57 kg to 68 kg	12,500 units
69 kg to 82 kg	15,000 units
83 kg to 98 kg	18,000 units
≥99 kg	18,000 units

Months 2 to 6

Table 4
Dose of FRAGMIN to be Administered Subcutaneously by Patient Weight during Months 2 to 6
Body Weight (kg)	FRAGMIN Dose (units) (prefilled syringe) once daily
≤56 kg	7,500 units
57 kg to 68 kg	10,000 units
69 kg to 82 kg	12,500 units
83 kg to 98 kg	15,000 units
≥99 kg	18,000 units

Safety and efficacy beyond six months have not been evaluated in patients with cancer and acute symptomatic VTE

[see Warnings and Precaution (5)and Adverse Reactions (6.1)]

)

Treatment of VTE in pediatric patients (see

The recommended starting dose according to pediatric age is provided in Table 5.

) (

2.4 Treatment of Symptomatic Venous Thromboembolism (VTE) in Pediatric Patients

The recommended starting dose according to pediatric age is provided in Table 5.

2 Years to less than 8 Years8 Years to less than 17 Years


Table 5
Starting Doses for Pediatric Patients with Symptomatic VTE
Age Group	Starting Dose
Birth (gestational age at least 35 weeks) to less than 2 Years	150 units/kg twice daily

125 units/kg twice daily

100 units/kg twice daily

Monitor anti-Xa level periodically in pediatric patients to maintain anti-Xa level between 0.5 units/mL and 1 unit/mL

[see Clinical Pharmacology (12.3)and Clinical Studies (14.5)]

The 3.8 mL multiple-dose vials of FRAGMIN contain 14 mg/mL of benzyl alcohol

[see Warnings and Precautions (5.3)]

Whenever possible, administer benzyl alcohol-free formulations (prefilled syringes) in pediatric patients

[see Warnings and Precautions (5.3)and Use in Specific Populations (8.4)]

The 10,000 units/4 mL (2,500 units/mL) single-dose vials are preservative-free. For treatment of neonates, use this vial presentation.

)

Age Group

Starting Dose

Birth (gestational age

at least 35 weeks) to less than 2 Years

150 units/kg twice daily

2 Years to less than 8 Years

125 units/kg twice daily

8 Years to less than 17 Years

100 units/kg twice daily

Do not use as intramuscular injection. FRAGMIN should not be mixed with other injections or infusions (

2.7 Administration

Latex Allergy:

Persons with latex allergies should not handle the FRAGMIN prefilled syringe because the needle shield may contain natural rubber latex which may cause allergic reactions.

FRAGMIN is administered by subcutaneous injection. It must not be administered by intramuscular injection.

FRAGMIN Injection should not be mixed with other injections or infusions unless specific compatibility data are available that support such mixing.

Subcutaneous injection technique: Patients should be sitting or lying down and FRAGMIN administered by deep subcutaneous injection. FRAGMIN may be injected in a U-shape area around the navel, the upper outer side of the thigh or the upper outer quadrangle of the buttock. The injection site should be varied daily. When the area around the navel or the thigh is used, using the thumb and forefinger, you

must

lift up a fold of skin while giving the injection. The entire length of the needle should be inserted at a 45 to 90 degree angle.

Inspect FRAGMIN prefilled syringes and vials visually for particulate matter and discoloration prior to administration.

After first penetration of the rubber stopper, store the multiple-dose vials at room temperature for up to 2 weeks. Discard any unused solution after 2 weeks.

Instructions for using the prefilled single-dose syringes preassembled with needle guard devices

Fixed dose syringes:

To ensure delivery of the full dose, do not expel the air bubble from the prefilled syringe before injection. Hold the syringe assembly by the open sides of the device. Remove the needle shield. Insert the needle into the injection area as instructed above. Depress the plunger of the syringe while holding the finger flange

until the entire dose has been given

. The needle guard will

not

be activated unless the

entire

dose has been given. Remove needle from the patient. Let go of the plunger and allow syringe to move up inside the device until the entire needle is guarded. Discard the syringe assembly in approved containers.

Graduated syringes:

Hold the syringe assembly by the open sides of the device. Remove the needle shield. With the needle pointing up, prepare the syringe by expelling the air bubble and then continuing to push the plunger to the desired dose or volume, discarding the extra solution in an appropriate manner. Insert the needle into the injection area as instructed above. Depress the plunger of the syringe while holding the finger flange

until the entire dose remaining in the syringe has been given

. The needle guard will

not

be activated unless the

entire

Figure

)

FRAGMIN (dalteparin sodium) injection is a sterile, aqueous, clear, colorless or straw-colored solution for injection, available in the following dosage forms and strengths:

•Injection: 2,500 units/ 0.2 mL, 5,000 units/ 0.2 mL, 7,500 units/ 0.3 mL, 12,500 units/ 0.5 mL, 15,000 units/ 0.6 mL, and 18,000 units/ 0.72 mL sterile, single-dose, prefilled syringes preassembled with a needle guard device.
•Injection: 10,000 units/mL sterile, single-dose, graduated syringes preassembled with a needle guard device.
•Injection: 95,000 units/ 3.8 mL (25,000 units/mL) sterile, multiple-dose vials.
•Injection: 10,000 units/ 4 mL (2,500 units/mL) sterile, single-dose vials.

Risk Summary

Available data from published literature and postmarketing reports have not reported a clear association with FRAGMIN and adverse developmental outcomes. There are risks to the mother associated with untreated VTE in pregnancy, and a potential for adverse effects on the preterm infant when FRAGMIN is used in pregnancy

(see

Clinical Considerations

)

. In animal reproduction studies, there was no evidence of embryo-fetal toxicity or teratogenicity when dalteparin sodium was administered to pregnant rats and rabbits during organogenesis at doses 2 to 4 times (rats) and 4 times (rabbits) the human dose of 100 units/kg dalteparin based on the body surface area

(see

Data

Animal Data

In reproductive and developmental toxicity studies, pregnant rats and rabbits received dalteparin sodium during organogenesis at intravenous doses up to 2,400 units/kg (14,160 units/m²) (rats) and 4,800 units/kg (40,800 units/m²) (rabbits). These exposures were 2 to 4 times (rats) and 4 times (rabbits) the human dose of 100 units/kg dalteparin based on the body surface area. These studies revealed no evidence of teratogenicity or embryo-fetal toxicity.

)

. Because animal reproduction studies are not always predictive of human response, FRAGMIN should be used during pregnancy only if clearly needed.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

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