Doraject

Description

Doraject™ injectable solution (doramectin injection) is a ready-to-use, colorless to pale yellow, sterile solution containing 1% w/v doramectin (10 mg/mL). In cattle, it is formulated to provide the recommended dosage of 200 mcg/kg of body weight when administered by subcutaneous (SC) or intramuscular (IM) injection at a rate of 1 mL per 110 lb of body weight. In swine, Doraject™ is designed to deliver the recommended dosage of 300 mcg/kg of body weight when given by IM injection at a rate of 1 mL per 75 lb of body weight.

Uses and Indications

This drug is indicated for the treatment and control of various parasitic infections in cattle and swine.

In cattle, it is effective against gastrointestinal roundworms, lungworms (adults and fourth stage larvae), eyeworms (adults), grubs (parasitic stages), sucking lice, and mange mites. Specific parasites targeted include Ostertagia ostertagi (including inhibited larvae), Haemonchus placei, Cooperia oncophora, Dictyocaulus viviparus, Thelazia spp., Hypoderma bovis, H. lineatum, Trichostrongylus axei, T. colubriformis, T. longispicularis, C. pectinata, C. punctata, Oesophagostomum radiatum, Bunostomum phlebotomum, Strongyloides papillosus, and Trichuris spp. This drug effectively controls infections and protects cattle from reinfection for varying durations: 14 days for Cooperia oncophora and Haemonchus placei, 21 days for Ostertagia ostertagi, and 28 days for C. punctata, Oesophagostomum radiatum, and Dictyocaulus viviparus.

In swine, the drug is indicated for the treatment and control of gastrointestinal roundworms, lungworms (adults), kidney worms (adults), sucking lice (adults and immature stages), and mange mites (adults and immature stages). Specific parasites include Ascaris suum, Oesophagostomum dentatum, Oesophagostomum quadrispinulatum, Strongyloides ransomi, Hyostrongylus rubidus, Metastrongylus spp., Stephanurus dentatus, Sarcoptes scabiei var. suis, and Haematopinus suis.

Limitations of use have not been specified; however, it is essential to follow appropriate guidelines for administration and dosage as per veterinary recommendations.

Dosage and Administration

Doraject™ injectable solution (doramectin injection) is administered to cattle and swine based on specific dosage guidelines tailored to the body weight of the animal.

For cattle, the recommended dosage is 200 mcg doramectin per kg (91 mcg/lb) of body weight. Each mL of Doraject™ contains 10 mg of doramectin, which is adequate to treat 110 lb (50 kg) of body weight. The following dosing schedule is provided based on body weight:

• 110 lb: 1 mL

• 220 lb: 2 mL

• 330 lb: 3 mL

• 440 lb: 4 mL

• 550 lb: 5 mL

• 660 lb: 6 mL

• 770 lb: 7 mL

• 880 lb: 8 mL

• 990 lb: 9 mL

• 1,100 lb: 10 mL

For swine, the recommended dosage is 300 mcg doramectin per kg (136 mcg/lb) of body weight. Each mL of Doraject™ contains 10 mg of doramectin, sufficient to treat 75 lb (34 kg) of body weight. The following dosing schedule is provided based on body weight:

• 15 lb: 0.2 mL

• 30 lb: 0.4 mL

• 45 lb: 0.6 mL

• 60 lb: 0.8 mL

• 75 lb: 1.0 mL

• 150 lb: 2.0 mL

• 225 lb: 3.0 mL

• 300 lb: 4.0 mL

• 375 lb: 5.0 mL

• 450 lb: 6.0 mL

It is imperative to avoid underdosing. Each animal must receive a complete dose based on its current body weight to ensure effective treatment and to prevent the development of parasite resistance.

Contraindications

This product is contraindicated for human use. It should not be administered to female dairy cattle 20 months of age or older, nor to calves intended for veal processing. Additionally, use in other animal species is contraindicated due to the risk of severe adverse reactions, including fatalities observed in dogs.

Underdosing is contraindicated, as it may lead to ineffective treatment and the development of parasite resistance. Furthermore, cattle should not be slaughtered for human consumption within 35 days post-treatment, and swine should not be slaughtered within 24 days post-treatment.

Environmental precautions must be observed; do not allow water runoff from feedlots to enter streams or ponds, and avoid contaminating water sources through direct application or improper disposal of drug containers. Containers should be disposed of in an approved landfill or incinerated.

Warnings and Precautions

Not for human use. This product is intended solely for veterinary applications and should be handled accordingly.

It is imperative to keep this product out of reach of children to prevent accidental ingestion or misuse.

Healthcare professionals are encouraged to report any suspected adverse drug events associated with this product. For technical assistance or to obtain a copy of the Safety Data Sheet, contact Cronus Pharma LLC at 1-844-227-6687 (1-844-2-CRONUS).

For further information regarding the reporting of adverse drug experiences related to animal drugs, healthcare professionals may contact the FDA at 1-888-FDA-VETS or visit their website at www.fda.gov/reportanimalae.

Side Effects

Severe adverse reactions, including fatalities, have been reported in dogs following the use of this product in other animal species. Participants should be aware that the destruction of Hypoderma larvae (cattle grubs) during critical developmental stages may lead to undesirable host-parasite reactions, which can also result in fatalities.

In particular, the elimination of H. lineatum when located in the tissue surrounding the gullet has been associated with the occurrence of bloat. Additionally, the removal of H. bovis from the vertebral canal may lead to staggering or paralysis in affected subjects. It is important to note that these adverse reactions are not exclusive to treatment with Doraject™; they may arise with any effective treatment targeting grubs.

Due to the potential for serious adverse reactions, this product is not intended for human use and should be kept out of reach of children.

Drug Interactions

Parasite resistance may develop to any dewormer, and this phenomenon has been reported across most classes of dewormers. To mitigate the risk of resistance, it is recommended that dewormers be used in conjunction with appropriate parasite management practices tailored to the specific geographic area and the animal(s) being treated.

Prior to administering any dewormer, it is essential to conduct fecal examinations or other diagnostic tests, along with a thorough review of the parasite management history, to ascertain the suitability of the product for the herd.

Post-treatment, the effectiveness of the dewormer should be monitored. This can be achieved through methods such as fecal egg count reduction tests or other appropriate evaluation techniques. A noted decrease in the effectiveness of a dewormer over time, as indicated by these tests, may suggest the emergence of resistance to the administered dewormer.

Packaging & NDC

The table below lists each NDC Code for Doraject (doramectin) veterinary formulations. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Studies have demonstrated the safety of the treatment in neonatal calves and piglets when administered doses up to three times the recommended amount. In both male (bulls and boars) and female (cows and sows) pediatric patients, the use of a dose three times the recommended amount did not adversely affect breeding performance during critical developmental stages, including folliculogenesis, implantation, organogenesis, and throughout gestation.

It is important to note that this treatment should not be used in calves intended for veal production.

Geriatric Use

Elderly patients may not have specific information regarding the use of Doraject™ (doramectin injection) in this population. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for geriatric patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to elderly patients. Monitoring for potential adverse effects may be prudent, given the lack of targeted data for this demographic.

Pregnancy

Doraject™ (doramectin injection) is not specifically indicated for use in pregnant animals, and caution should be exercised when administering this product to pregnant cattle and swine. Available studies have demonstrated safety in female cows and sows during critical reproductive phases, including folliculogenesis, implantation, organogenesis, and throughout gestation, when administered at doses up to three times the recommended amount. Notably, these studies reported no adverse effects on breeding performance.

While there are no specific dosage modifications provided for pregnant animals, it is recommended that veterinarians be consulted for guidance on treatment during pregnancy to ensure the safety of both the pregnant animal and the developing fetus. Additionally, Doraject™ is contraindicated in other animal species due to the potential for severe adverse reactions, including fatalities, which could indirectly impact pregnant animals if they are exposed to treated animals. Therefore, healthcare professionals should exercise caution and consider the potential risks when treating pregnant animals with this product.

Lactation

There is no specific information available regarding the use of this medication in lactating mothers. The prescribing information does not address the excretion of the drug in breast milk or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

Studies have demonstrated the safety margin of doramectin injection in cattle and swine. In trials conducted in the USA, no toxic signs were observed in cattle administered doses up to 25 times the recommended dose, nor in swine given doses up to 10 times the recommended dose.

Teratogenic effects were not evident, as no increase in fetal malformations was observed in relevant studies. Non-teratogenic effects were also noted, with studies indicating safety in neonatal calves and piglets treated with doses up to three times the recommended level. Furthermore, in both male (bulls and boars) and female (cows and sows) subjects during critical reproductive phases such as folliculogenesis, implantation, organogenesis, and throughout gestation, a dose three times the recommended level did not adversely affect breeding performance.

Doramectin is derived from fermentations of selected strains of the soil organism Streptomyces avermitilis. The primary mode of action of macrocyclic lactones, including doramectin, involves the modulation of chloride ion channel activity within the nervous systems of nematodes and arthropods. These compounds bind to specific receptors that enhance membrane permeability to chloride ions, leading to the inhibition of electrical activity in nerve cells of nematodes and muscle cells of arthropods, ultimately resulting in paralysis and death of the parasites. In mammals, the neuronal receptors targeted by macrocyclic lactones are primarily located within the central nervous system (CNS), where doramectin achieves only negligible concentrations.

Postmarketing Experience

Reports of suspected adverse drug events have been received voluntarily and through surveillance programs. For technical assistance or to obtain a copy of the Safety Data Sheet, individuals may contact Cronus Pharma LLC at 1-844-227-6687 (1-844-2-CRONUS).

Additionally, for further information regarding adverse drug experience reporting for animal drugs, the FDA can be contacted at 1-888-FDA-VETS or through their website at www.fda.gov/reportanimalae.

It has been noted that parasite resistance may develop to any dewormer, with such occurrences reported for most classes of dewormers. Furthermore, a decrease in a drug’s effectiveness over time, as determined by fecal egg count reduction tests, may suggest the development of resistance to the administered dewormer.

Patient Counseling

Healthcare providers should advise patients to consult their veterinarian for assistance in the diagnosis, treatment, and control of parasitism. It is important to emphasize that the product is not intended for human use and should be kept out of reach of children.

Patients should be informed about the potential for parasite resistance to develop with any dewormer, as this has been reported for most classes of dewormers. To mitigate this risk, treatment with a dewormer should be used in conjunction with appropriate parasite management practices tailored to the geographic area and the specific animal(s) being treated. Prior to the use of any dewormer, fecal examinations or other diagnostic tests, along with a review of the parasite management history, should be conducted to determine the product's appropriateness for the herd.

Following the administration of any dewormer, patients should monitor the effectiveness of the treatment. This can be achieved through methods such as a fecal egg count reduction test. A decrease in the drug's effectiveness over time, as indicated by these tests, may suggest the development of resistance to the dewormer. Consequently, patients should be encouraged to adjust their parasite management plan based on regular monitoring results.

For cattle treated with Doraject™ after the heel fly season, it is safe to re-treat during the winter for internal parasites, mange mites, or sucking lice, without the risk of grub-related reactions. Healthcare providers should recommend a planned parasite control program and consult with veterinarians regarding the appropriate timing for treatment.

Patients should also be informed about the process for reporting suspected adverse drug events. They can contact Cronus Pharma LLC at 1-844-227-6687 (1-844-2-CRONUS) for technical assistance or to obtain a copy of the Safety Data Sheet. For additional information on adverse drug experience reporting for animal drugs, patients can reach out to the FDA at 1-888-FDA-VETS or visit www.fda.gov/reportanimalae.

Finally, healthcare providers should instruct patients on the proper disposal of containers, recommending that they be disposed of in an approved landfill or by incineration.

Storage and Handling

Doraject™ (doramectin injection) is supplied in multi-dose, rubber-stoppered glass vials with the following configurations: 100 mL, 250 mL, and 500 mL.

For optimal storage, Doraject™ should be maintained at a temperature range of 2°C to 8°C (36°F to 46°F). It is essential to protect the vials from light and to avoid freezing. Proper handling procedures should be followed to ensure the integrity of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This document includes the full labeling information for Doraject, as submitted by Cronus Pharma LLC for veterinary use. It may include dosage by species, withdrawal periods, and administration instructions.

View veterinary label (PDF)