Cathflo Activase 2mg Alteplase

Alteplase is a recombinant human tissue-type plasminogen activator (tPA). It binds to fibrin in a thrombus and converts the entrapped plasminogen to plasmin. Plasmin then initiates local fibrinolysis by degrading fibrin, fibrinogen, and other plasma proteins. For catheter clearance, this action helps dissolve fibrin clots causing occlusion.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Note: In rare cases, allergic reactions can be fatal.
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Difficulty speaking or thinking
+ Changes in balance
+ Drooping on one side of the face
+ Blurred vision
Severe headache
Severe stomach pain
Redness, swelling, or pain at the catheter site
* Swelling, warmth, numbness, color changes, or pain in a leg or arm

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have side effects that bother you or persist, contact your doctor for guidance.

Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor.

To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
When discussing your allergies, be sure to describe the symptoms you experienced.

Additionally, this medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Share information about any health problems you have
You must verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are breast-feeding, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of using this medication during pregnancy or breast-feeding to make an informed decision about its use.

• Anticoagulants (e.g., warfarin, heparin, direct oral anticoagulants): Increased risk of bleeding.
• Antiplatelet agents (e.g., aspirin, clopidogrel, ticagrelor): Increased risk of bleeding.
• Other thrombolytic agents: Increased risk of bleeding.

• NSAIDs (e.g., ibuprofen, naproxen): May increase risk of bleeding.
• SSRIs/SNRIs: May increase risk of bleeding.

• Unusual bleeding or bruising
• Blood in urine or stools (dark or red)
• Nosebleeds
• Gum bleeding
• Headache (severe or unusual)
• Dizziness or lightheadedness
• Weakness
• Allergic reaction symptoms (rash, itching, hives, swelling, difficulty breathing)

Alteplase is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic use has been associated with bleeding complications in the mother and fetus.

Alteplase is considered L3 (moderately safe) for lactation. It has a very short half-life, making infant exposure through breast milk unlikely to be significant. Caution is advised, but breastfeeding may be continued with monitoring for infant bleeding.

Dosing for catheter clearance is established for pediatric patients based on weight and catheter lumen volume. Safety and efficacy have been demonstrated. Close monitoring for bleeding is crucial, especially in very young or low-weight infants.

No specific dose adjustment is required based on age. However, elderly patients may have an increased risk of bleeding complications due to age-related physiological changes or concomitant medications. Monitor closely for signs of bleeding.

• Cathflo Activase is specifically formulated and dosed for intraluminal instillation to clear occluded central venous catheters, not for systemic thrombolysis.
• Ensure proper instillation technique: instill the entire volume into the occluded lumen, do not force the solution, and allow it to dwell for the recommended time.
• Aspirate the drug and residual clot after the dwell time to prevent systemic exposure.
• If the catheter remains occluded after two doses, consider alternative methods for catheter clearance or replacement.
• Always check for contraindications to thrombolytic therapy, even for local use, especially conditions that increase bleeding risk.

• Mechanical methods for catheter clearance (e.g., guidewire manipulation)
• Catheter exchange or replacement
• Ethanol lock (for some types of occlusions, e.g., lipid build-up, biofilm)
• Urokinase (historically used, but no longer marketed in the US for this indication)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.